manufacturing director

Rittal LLC

<div>
 
 Proven Leadership, Hard Work and Innovation Alive and Well in North America
 
 
 
 Rittal North America has built a strong tradition of innovation and takes pride in a progressive approach to engineering. We design and manufacture the world&rsquo;s leading industrial and IT enclosures, racks, and accessories, including high‑efficiency, high‑density power management, and climate control systems for industrial, data center, outdoor, and hybrid applications.
 
 
 The Director, Manufacturing Engineering is responsible for leading capital project development, Lean Manufacturing initiatives, equipment procurement, and continuous improvement strategies that elevate plant performance. This role partners closely with Production, Maintenance, and cross‑functional teams to optimize operations, strengthen safety culture, and support world‑class manufacturing through the Rittal Production System.
 
 
 
 Why Work At Rittal:
 
 
 
 <ul>
 <li>
 401K Match
 </li>
 <li>
 Above average benefits available on the 1st of the month after you start
 
 
 </li>
 </ul>
 
 Key Responsibilities:
 
 
 
 <ul>
 <li>
 Direct manufacturing engineering activities involved in capital project development, equipment procurement, and project implementation.
 </li>
 <li>
 Coordinate the development of plant layouts through collaboration with all internal disciplines.
 </li>
 <li>
 Define and execute a clear Lean Manufacturing vision, including strategies to drive lean culture, implement Lean/Six Sigma techniques, maintain an agile SFM process, train teams in problem‑solving methods, strengthen workplace design, apply SMED, lead Kaizen events, and ensure capacity is managed through Takt and optimized line balancing.
 </li>
 <li>
 Work closely with Production and other departments to implement cost‑reduction initiatives.
 </li>
 <li>
 Meet or exceed targets for Quality, Productivity, Uptime, On‑Time Delivery, and Cost.
 </li>
 <li>
 Provide leadership and performance management to drive high employee engagement.
 </li>
 <li>
 Support continuous improvement efforts and contribute to achieving a world‑class manufacturing environment through the Rittal Production System.
 </li>
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 Manage and develop vendor relationships for tooling, fixtures, and equipment.
 </li>
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 Deliver weekly updates on improvement projects and equipment initiatives.
 </li>
 <li>
 Own overall equipment effectiveness (OEE) performance for the facility, driving sustained improvements in availability, performance, and quality metrics.
 </li>
 <li>
 Provide direct leadership and accountability for the Maintenance function, including equipment reliability, preventive maintenance execution, and rapid response strategies for unplanned downtime.
 </li>
 <li>
 Lead root‑cause analysis, corrective action development, and long‑term reliability improvements to eliminate chronic equipment failures.
 </li>
 <li>
 Ensure maintenance planning, PM programs, and reliability engineering activities align with production goals and long‑term capital plans.
 </li>
 <li>
 Promote and inspire a strong safety culture, ensuring a safe workplace aligned with organizational safety goals.
 </li>
 <li>
 Investigate, justify, and implement capital equipment and process changes to support operational needs.
 </li>
 <li>
 Lead efficient project meetings to communicate progress, track action items, and maintain cost, schedule, and quality expectations.
 </li>
 <li>
 Participate in or lead corrective action teams.
 </li>
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 Oversee development and implementation of work instructions and process routings to support production planning, process efficiency, estimating, and capacity planning.
 </li>
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 Actively participate in design reviews for Engineering Change Notices (ECN) and New Product Introductions (NPI).
 </li>
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 Support budget development and capacity‑planning simulations.
 </li>
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 Engage with peers and management to foster a positive workplace culture.
 </li>
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 Continuously pursue skill growth and competency development for self and team.
 </li>
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 Lead and/or support 6S activities.
 
 
 </li>
 </ul>
 
 Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Mechanical or Industrial Engineering or similar, required.
 </li>
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 Excellent communication and presentation skills, including presenting to Executive Management.
 </li>
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 Strong background in Lean Manufacturing and Six Sigma methodologies.
 </li>
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 Strong analytical skills and work ethic.
 </li>
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 Thorough knowledge of sheet metal fabrication, welding, powder coating, and/or stamping.
 </li>
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 Proven leadership and strong interpersonal communication skills.
 </li>
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 Proficiency in Microsoft Office tools.
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 Ability to work within a matrixed environment.
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 Ability to travel up to 15%.
 
 
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 </ul>
 #UrbIND
 
 
 If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may contact the company&rsquo;s Human Resources Department at (937) 399-0500.
 
 
 This option is reserved for individuals who require accommodation due to a disability.
 
 
 Rittal LLC and Eplan are proud to be an affirmative action/equal opportunity employer. EEO, including Disability/Vets.
</div>

Director, Manufacturing Engineering

Fluence Energy

<div>Fluence (Nasdaq: FLNC) is a global market leader delivering intelligent energy storage and optimization software for renewables and storage. Our solutions and operational services are helping to create a more resilient grid and unlock the full potential of renewable portfolios. With gigawatts of successful implementations across nearly 50 markets, we are transforming the way we power our world for a more sustainable future. For more information, please visit fluenceenergy.com .
Job Description:
Role Overview
The Director, Operations &ndash; US Enclosures Manufacturing is accountable for the performance, scalability, and execution of Fluence&rsquo;s U.S. enclosure manufacturing operations.
This role owns the end-to-end enclosure manufacturing system across contract manufacturers, ensuring enclosure fabrication and assembly meet Fluence&rsquo;s requirements for quality, cost, schedule, and scalability.
The Director ensures enclosure manufacturing operates as a high-performing, scalable production system aligned with enterprise manufacturing strategies, standardized tools, and operating processes.
<h2 class="jobSectionHeader">Key Responsibilities
</h2>Enclosure Manufacturing Ownership:
<ul><li>Own performance of U.S.-based enclosure manufacturing across contract manufacturers
</li><li>Drive production outcomes across schedule, cost, quality, and throughput
</li><li>Ensure manufacturing capacity, readiness, and scalability
</li><li>Identify and resolve systemic constraints impacting production
</li></ul>Manufacturing System Performance &amp; Scalability:
<ul><li>Ensure enclosure manufacturing operates as a cohesive, high-performing system
</li><li>Balance production flow and eliminate bottlenecks across fabrication and assembly
</li><li>Drive improvements in efficiency, cost structure, and throughput
</li><li>Support scaling of enclosure manufacturing to meet demand
</li></ul>Contract Manufacturer Management:
<ul><li>Own relationships with CM partners executing enclosure manufacturing
</li><li>Ensure accountability for performance, cost, quality, and delivery commitments
</li><li>Drive continuous improvement and operational maturity across partners
</li><li>Align CM capabilities with Fluence manufacturing standards and expectations
</li></ul>Cross-Functional &amp; Cross-Domain Alignment:
<ul><li>Partner with Engineering, Product, Supply Chain, Quality, and Delivery teams
</li><li>Provide manufacturing input into design, configuration, and change decisions
</li><li>Collaborate with peer manufacturing operations leaders to align on priorities, capacity planning, and execution strategies
</li><li>Ensure enclosure manufacturing aligns to enterprise manufacturing system needs and avoids siloed processes
</li></ul>Operating Model, KPIs &amp; Process Standardization:
<ul><li>Operate within and reinforce standardized manufacturing operating models and tools
</li><li>Partner with the Operations Process Excellence Manager to ensure consistent KPI definitions and reporting
</li><li>Align on standard dashboards, reporting cadences, and performance visibility
</li><li>Drive lessons learned capture and sharing across manufacturing domains
</li></ul>People Leadership:
<ul><li>Lead and develop Operations Managers / Manufacturing Leads
</li><li>Build a high-performing, accountable team culture
</li><li>Strengthen team capability in manufacturing operations and supplier management
</li></ul>Risk Management &amp; Quality:
<ul><li>Identify and manage risks across manufacturing execution and supplier performance
</li><li>Ensure adherence to Fluence quality standards
</li><li>Drive root cause analysis and continuous improvement
</li></ul>Our Culture
At Fluence, our culture is the foundation that drives our ambitious growth strategy and fuels our mission to transform the future of energy. Our core cultural pillars empower us to innovate, collaborate, and lead with purpose, ensuring we continue to deliver unparalleled value to our customers and the world.
Unleash Voices
We believe every voice matters. We encourage openness, active listening, and decisive action to create a culture where everyone has the opportunity to contribute to our success. We foster an environment where diverse perspectives are heard and valued, driving innovation and progress.
Customer Fluent
Our customers are at the heart of everything we do. We&rsquo;re committed to delivering exceptional value that exceeds expectations by understanding our customers' needs and adapting swiftly to meet them. Our deep focus on customer satisfaction drives us to continuously improve and innovate.
Infinite Impact
We are committed to creating the impossible. We push boundaries to deliver sustainable, game-changing solutions that shape a brighter, more energy-efficient future for all. Our team is passionate about making a lasting impact that will resonate for generations to come.
All In
We are all in for growth. Our teams are relentlessly focused on identifying and seizing opportunities that propel us forward. We embrace an ownership mindset, pushing ourselves and each other to accelerate progress and create lasting success.
Equal Opportunity Employer
 
At Fluence, we believe great teams are built on a collaborative and connected culture. We&rsquo;re proud to be an Equal Opportunity Employer and welcome qualified applicants of all backgrounds. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity or expression, genetic information, or any other status protected by law.
Work Authorization
 
To join our team, you&rsquo;ll need to be legally authorized to work in the United States at the time of application and throughout your employment, without the need for employer sponsorship. Please note that Fluence does not sponsor work visas for this position.</div>

Director - Enclosure Manufacturing, US

Janicki Industries

<div>Janicki Industries is an innovative, family-owned aerospace company located at the foot of the Cascades. We focus on engineering and manufacturing complex projects for companies in the aerospace, defense, and space industries. We are looking for a Director of Operations on the weekend shift to join our growing team.

Off-Shift Differential of $12,000 Annually Applies for Weekend Shift.

POSITION DESCRIPTION

This position is located on-site in Hamilton and Sedro Woolley, Washington State.

The Director of Operations oversees and manages daily production processes encompassing the fabrication, finishing, and assembly of composite and metal parts and tooling. This role requires exceptional leadership and communication skills to effectively coordinate across diverse organizational boundaries and disciplines. The Director is instrumental in driving productivity, maintaining stringent quality standards, and fostering teamwork and collaboration to achieve organizational goals.

The following essential job functions are performed as a Director of Operations:
<ul>
<li>Directly responsible for the daily function and safe operations of manufacturing cells and supervision of cell managers</li>
<li>Plans, direct, and coordinate manufacturing processes to provide a consistent flow of deliverables</li>
<li>Analyzes and plans work force utilization, space requirements, and workflow for optimal use of resources</li>
<li>Estimates production times, staffing requirements, and related costs to provide information for management decisions</li>
<li>Maintains heightened awareness of schedule for every project moving through the value stream to meet key project milestones</li>
<li>Interprets a broad range of engineering specifications including drawings, sketches, and written requirements</li>
<li>Interviews, hires and trains next tier of technicians and leads to complete assigned work</li>
<li>Works with project managers to identify and mitigate risk in the production process</li>
<li>Determine product specifications and arrange for purchase of equipment, or non-standard materials and monitors availability and delivery times with respect to production schedule</li>
<li>Recommends and administers policies and procedures to enhance manufacturing and support operations</li>
<li>Reviews weekly and monthly project status reports and evaluate that schedules or plans will meet customer timelines</li>
<li>Supports and enforces published company policies</li>
</ul><ul><li>Must work well under pressure, meeting and completing multiple deadlines</li>
</ul><ul><li>Must be at work on time and maintain good attendance. This is a condition of employment and is an essential function of the job</li>
<li>Performs other duties as assigned</li>
</ul>
QUALIFICATIONS
<ul>
<li>Due to our ITAR and EAR regulations, applicants must be a US Citizen or of Legal Permanent Resident Status as defined by 8 U.S.C. 1324b (a) (3)</li>
<li>This position requires the ability to obtain a U.S. Secret Security Clearance (U.S. Citizenship Required). Janicki will assist with gaining this access once employed. Special Access Program or other Government Access Requirements are mandatory for this position and requires candidate agreed to enter a Continuous Evaluation program</li>
</ul>
EDUCATION/EXPERIENCE
<ul>
<li>Education: Bachelor&rsquo;s degree in Manufacturing Engineering, Engineering Technology, Mechanical Engineering, Composite/Material Sciences, Industrial Design Technology, or a related field.</li>
<li>Experience: 5-10 years of management experience in aerospace composites or a related field.</li>
<li>Industry Knowledge: Familiarity with AS9100 and NADCAP compliance standards, as well as key composite field concepts, practices, and procedures.</li>
<li>Technical Skills: Proficiency in Microsoft Office and CAD software; experience with CATIA is a plus.</li>
<li>Operational Expertise: Experience managing workflows through machine centers is preferred.</li>
<li>Skills: Strong problem-solving, communication, and teambuilding skills, combined with a high degree of creativity and initiative.</li>
<li>Language: Effective verbal and written communication skills in English.</li>
<li>Security Clearance: Must be willing and eligible to obtain a government-issued security clearance.</li>
</ul>ADDITIONAL INFORMATION
<ul>
<li>Salary range for this role is between $130,000-190,000, plus discretionary bonus, 401(k) matching, vacation, and health benefits. Employees can also receive additional pay for off shifts. The range provided is Janicki&rsquo;s estimate of the base compensation for this role. Actual amount offered will be based on job-related and non-discriminatory factors such as experience, location, education, training, skills, and abilities</li>
<li>By applying for this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified, you may be contacted for this and future openings</li>
</ul>
BENEFITS
<ul>
<li>Medical, dental, and vision insurance with employer contribution</li>
<li>Disability insurance as well as Life/AD&amp;D insurance</li>
<li>HSA (Health Savings Account) with employer contribution and FSA (Flexible Savings Account)</li>
<li>401k with employer matching</li>
<li>Paid time off and paid holidays (including two floating holidays)</li>
<li>Education reimbursement program</li>
<li>Several shift options</li>
<li>Premium pay for off shifts</li>
</ul>
Not sure that you&rsquo;ll be the perfect fit for this role? You should still apply! We&rsquo;ll review your application for other opportunities. We are always on the lookout for talented people!

Janicki Industries is an Equal Opportunity Employer. Janicki Industries does not discriminate on the basis of race, color, religion, sex, national origin, sexual orientation, marital or familial status, physical or mental disability, genetic information, age, retaliation, veteran/military service status, or any other legally protected status. Janicki is proud to be a military friendly employer.

Applicants or employees wishing to view a copy of Janicki Industries&rsquo; Affirmative Action Plan for veterans and individuals with disabilities, or applicants requiring reasonable accommodation to the application/interview process should notify the Human Resources Department at (360) 404-1997.

As a federal government contractor and a recipient of federal funding, Janicki is required to abide by federal drug testing requirements (including preemployment drug testing for cannabis). Additionally, because of Janicki&rsquo;s work on aerospace products and the high volume of safety sensitive positions, Janicki takes the safety of its employees very seriously and requires that employees pass a preemployment drug test prior to starting employment.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.</div>

Director of Operations (Weekend Day Shift)

GE Vernova

<div>
 
 Job Description Summary
 
 
 
 GE Vernova Hydro Power is seeking a Project Director. In this role you will be responsible for the project delivery, Profit &amp; Loss accountability, and Customer Satisfaction (including Voice of Customer) through management of project related activities and resources. The Project Director is assigned to execute directly one or more large projects (Variable role).
 
 
 The Project Director owns/influences budgets and operating plans and is fully accountable for the financial results/KPIs of the projects managed within the Cluster. Internally, he manages the Project Managers in the cluster (in terms of priorities, performance, and development). Externally, he manages the relationship with external customers as the first level of escalation.
 
 
 The role is guided by operating policy. Works with cross functional teams. The role has autonomy within the operational area or a segment within a larger business unit. The role may have a major impact on a small business unit or Family within a Function or P&amp;L. High levels of evaluative judgement and operational acumen are required to achieve outcomes and targets.
 
 
 
 Job Description
 
 
 
 
 Roles and Responsibilities
 
 
 
 <ul>
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 Responsible for overseeing the projects and direct or indirect leadership and/or management of project resources for small-medium sized projects (size in relation to GEV Hydro company) that may include equipment-only, suites of products or turnkey projects.
 
 
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 Typically, a 2nd line manager with senior and lead professional direct reports. Has the ability to attract and retain talent. Often manages small teams. Developing expertise in own function. May include roles that are experts in their discipline, providing professional or thought leadership. Influences policy and ensures delivery within area of responsibility, linking with other parts of the organization.
 
 
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 Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Utilizes understanding of industry trends to inform decision making process.
 
 
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 Leads others to find creative solutions within complex manufacturing processes with technical variety and/or interdependent production cycles. Employs sophisticated operational/product management, manufacturing or engineering techniques. Interaction with adjacent functions needed to solve issues. Has the ability to evaluate quality of information received and questions conflicting data for analysis. Uses multiple internal and external resources outside of own function to help arrive at a decision.
 
 
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 May lead functional teams or projects with moderate resource requirements, risk, and/or complexity. Presents business or technical discipline solutions to leaders. Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and may negotiate with external partners, vendors, or customers.
 
 
 </li>
 </ul>
 
 Required Qualifications
 
 
 
 <ul>
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 Bachelor&rsquo;s Degree in Engineering and/or Business Management from an accredited university
 
 
 </li>
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 More than 10 years of experience with focus on Project Management and/or International Project Execution
 
 
 </li>
 <li>
 Solid experience in EPC (Engineering / Procurement / Construction), Energy or Manufacturing Industry
 
 
 </li>
 <li>
 Strong commercial/contract and financial acumen
 
 
 </li>
 <li>
 Strong focus on Quality, Environmental, Health and Safety (EHS) mindset and compliance
 
 
 </li>
 <li>
 Customer Service and advocate mindset
 
 
 </li>
 <li>
 Strong computer skills including MS Word, Excel, Project and PowerPoint and knowledge of Database operations
 
 
 </li>
 <li>
 Fluent in English
 
 
 </li>
 <li>
 Ability and willingness to travel domestically (including to sites in Pakistan) and internationally in the region as required (minimum expected around 30%)
 
 
 </li>
 </ul>
 
 Desired Qualifications
 
 
 
 <ul>
 <li>
 Master&rsquo;s Degree, preferably MBA is a strong adder
 
 
 </li>
 <li>
 Professional experience in Hydro or Power Generation will be highly regarded
 
 
 </li>
 <li>
 Ability to build strong local and regional relationships with customers, and ensure customer satisfaction
 
 
 </li>
 <li>
 Additional languages skills would be a plus
 
 
 </li>
 <li>
 Experience within matrix, cross-functional and global team organizations
 
 
 </li>
 <li>
 Highly self-driven and self-motivated
 
 
 </li>
 </ul>
 
 
 
 Additional Information
 
 
 
 
 
 
 Relocation Assistance Provided:
 
 No
</div>

Project Director

Amgen

<div><div>United States - Remote
<div>JOB ID: R-247374 LOCATION: United States - Remote ; Ireland - Remote; Puerto Rico - Remote; Singapore - Remote WORK LOCATION TYPE: Remote DATE POSTED: Jun. 12, 2026 CATEGORY: Quality SALARY RANGE: 145,241.20USD -196,502.80 USD
</div></div><div><div>Join Amgen&rsquo;s Mission of Serving Patients
At Amgen, if you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. Our shared mission&mdash;to serve patients living with serious illnesses&mdash;drives all that we do.
Since 1980, we&rsquo;ve helped pioneer the world of biotech in our fight against the world&rsquo;s toughest diseases. With our focus on four therapeutic areas &ndash;Oncology, Inflammation, General Medicine, and Rare Disease&ndash; we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you&rsquo;ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you&rsquo;ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 
Quality Compliance Associate Director &ndash; Aseptic Processing 
 What you will do
Let&rsquo;s do this. Let&rsquo;s change the world. In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical decisions.
This is a full-time remote position
Specific responsibilities include but are not limited to:<ul><li>
Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance, Manufacturing, and site teams.</li><li>
Support the contamination control program, including site engagement, network participation, metrics review, risk identification, and escalation of significant concerns.</li><li>
Contribute to the development, revision, and implementation of global aseptic processing and contamination control standards, procedures, technical guidance, and quality intelligence documents.</li><li>
Support periodic contamination control reviews, trend evaluations, and state-of-control assessments for in-scope sites, processes, and products.</li><li>
Provide technical input for environmental monitoring, bioburden control, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls.</li><li>
Partner with site Quality, Manufacturing, Engineering, and QC laboratories to promote consistent application of contamination control expectations.</li><li>
Provide technical review and recommendations for microbiology investigations, deviations, CAPAs, risk assessments, change controls, audit observations, and inspection commitments.</li><li>
Support evaluation and implementation of new or improved technologies, practices, and contamination control tools.</li><li>
Contribute to Global Aseptic Council activities, technical forums, communities of practice, and network alignment discussions.</li><li>
Support regulatory inspections, internal audits, health authority commitments, and inspection-readiness activities related to microbiology, contamination control, QC laboratories, and manufacturing controls.</li><li>
Provide technical input to audit responses, regulatory inspection responses, CAPA plans, and effectiveness checks.</li><li>
Review regulatory filings, responses, or technical documents for aseptic processing -related content, as assigned.</li><li>
Monitor relevant regulatory, compendial, and industry developments and help translate them into practical expectations for sites and functions.</li><li>
Lead or support cross-functional projects related to aseptic processes, contamination control, laboratory practices, inspection readiness, or quality improvement.</li></ul>
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality Compliance Associate Director &ndash; Aseptic processing we seek is an experienced, collaborative subject matter expert with these qualifications.
Basic Qualifications:<ul><li>
Doctorate degree and 3 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR</li><li>
Master&rsquo;s degree and 7 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR</li><li>
Bachelor&rsquo;s degree and 9 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience</li><li>
Associate&rsquo;s degree and 12 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR</li><li>
High school diploma / GED and 14 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience</li></ul>
In addition to meeting at least one of the above requirements, you must have a minimum of 3 years&rsquo; experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:<ul><li>
Life Science, Microbiology, Biology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific academic background.</li><li>
8+ years of experience in Quality, QC microbiology, Manufacturing, contamination control, sterility assurance, or a related GMP function within the biotechnology or pharmaceutical industry.</li><li>
3 years of experience in aseptic processing, leading, environmental monitoring programs, or contamination control technical workstreams.</li><li>
Strong technical knowledge of aseptic processing, microbiology and contamination control practices, including environmental monitoring, bioburden, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls.</li><li>
Experience supporting GMP investigations, deviations, CAPAs, change controls, risk assessments, audits, inspection readiness, or regulatory inspection activities.</li><li>
Experience in biologics, sterile manufacturing, aseptic processing, drug substance manufacturing, drug product manufacturing, or QC microbiology laboratory operations.</li><li>
Experience contributing to global or multi-site standards, procedures, technical guidance, training materials, quality intelligence, or quality system improvements.</li><li>
Ability to interpret and apply GMP, GxP, regulatory, compendial, and industry expectations to microbiology, manufacturing, Quality Control, and contamination control processes.</li><li>
Experience supporting or participating in technical networks, communities of practice, Centers of Excellence, or cross-site microbiology forums.</li><li>
Experience evaluating or implementing new manufacturing technologies, rapid microbiological methods, automation, data trending tools, or contamination control improvements.</li><li>
Demonstrated ability to lead cross-functional teams, influence without direct authority, communicate complex technical information clearly, and manage multiple priorities.</li><li>
Ability to work effectively with global and virtual teams across time zones while adapting approaches based on technical complexity, regulatory considerations, and stakeholder needs.</li><li>
Effective English written and verbal communication skills; additional language capability is a plus.</li><li>
Ability to travel domestically and internationally up to 20% of the time.</li></ul>
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we&rsquo;ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:<ul><li>
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts</li><li>
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>
Stock-based long-term incentives</li><li>
Award-winning time-off plans</li><li>
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.</li></ul>
 and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</div></div></div>

Quality Compliance Associate Director - Aseptic Processing

Eli Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader, headquartered in Indianapolis, Indiana. Our 40,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
 Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the site technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
 The Associate Director – Engineering (Automation) is responsible for the supervision of the process control engineers and technicians that support the daily operations of the facility. The Associate Director is also responsible for the productivity and development of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing of API drug substances. Additionally, the Associate Director partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.
 In the project delivery phase and startup phase of the project, leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.
 
Responsibilities:Pre-Startup and Startup Phase: 
<ul>
<li>Attract, hire, and onboard top talent to the Process Control Engineering team, establishing the right attitude, curiosity, and learning agility to deliver on the site mission.</li>
<li>Build the organization with the necessary capability, capacity, and culture to operate this facility to the highest standards of safety, quality, and operational excellence.</li>
<li>Develop and implement the business systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external experience.</li>
<li>Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.</li>
<li>Support the project team to deliver the facility by providing feedback and support on design decisions, commissioning & qualification strategies, and automation-related deliverables.</li>
<li>Collaborate with the project team to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.</li>
<li>Organize and implement strategy for creating standard automation and process control operating procedures (SOPs) for startup and post-startup phases.</li>
<li>Plan and manage business operational expenses, capital, and headcount targets.</li>
</ul>
Post-Startup: 
<ul>
<li>Supervise and coach process control team, including completing performance reviews and development plans.</li>
<li>Staffing, including recruiting, resource planning, and succession planning.</li>
<li>Process control work coordination.</li>
<li>Review and monitor financial performance; commit to meeting targets.</li>
<li>Develop and implement the Process Control Engineering Business Plan.</li>
<li>Demonstrate a commitment to environmental, health, and safety (including PSM).</li>
<li>Identify, track, and report key indicators of functional performance.</li>
<li>Ensure team is operating in a state of compliance.</li>
<li>In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.</li>
<li>Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting.</li>
<li>Review and approve automation-related deviations and change controls.</li>
<li>Review and approve automation and process control standard operating procedures (SOPs).</li>
<li>Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, validations, procedures, and control strategies.</li>
<li>Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.</li>
<li>Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.</li>
<li>Be a fully active member of the flow leadership in running the plant, including participating on management sub-teams.</li>
<li>Develop future management and technical expert leadership for the site.</li>
</ul>
Basic Qualifications: 
<ul>
<li>Minimum B.S. in Engineering (preferably Chemical Engineering)</li>
<li>5 + years of experience in Process Control and Automation Engineering, preferably in API manufacturing.</li>
<li>3+ years of related leadership experience</li>
</ul>
Additional Skills/Preferences: 
<ul>
<li>Experience with automation platforms including Rockwell Automation and Emerson DeltaV.</li>
<li>Ability to instill teamwork within the department and demonstrate key interpersonal skills.</li>
<li>Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.</li>
<li>Successful application of organizational models through recruiting and retention of employees.</li>
<li>Ability to make decisions independently and to network with others as appropriate.</li>
<li>Ability to function in a team environment as a leader and as a member of management teams.</li>
<li>State licensure as a Professional Engineer is not required but is encouraged.</li>
</ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
 
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
 
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
 $123,000 - $180,400
 
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
 
#WeAreLilly

Associate Director - Engineering (Automation)

SQA Services, Inc.

<div>
 
 SQA protects through quality.
 
 We have a global footprint that supports complex and highly
 
 
 regulated supply chains. The partnerships SQA has created over the past 30 years have benefitted
 
 
 our clients&rsquo; integrated strategies, which SQA can support annually. SQA works with its
 
 
 client partners and their supply chain in over 90 countries annually, deploying over 1000 associates.
 
 
 SQA understands the complexity and challenges of a global supply chain, and our clients see that
 
 
 The results from SQA exceed their internal efficiencies. Annually, SQA performs over 3,000 audits, 3
 
 
 million parts inspected at the source, and 70,000 hours of Engineering Supplier Development. This
 
 
 occurs in the form of managed programs at their suppliers that include, but may not be limited to,
 
 
 audits, assessments, supplier development, part approvals, inspection, remediation, self-release,
 
 
 and full-time surveillance.
 
 
 
 Overview:
 
 
 As a
 
 Senior Process Engineer
 
 at SQA Services, you will play a pivotal role in enhancing
 
 
 SQA&rsquo;s organizational efficiency and effectiveness by implementing and overseeing continuous
 
 
 improvement initiatives. Process Engineering plays a vital role in identifying
 
 
 areas for improvement, analyzing processes, and developing strategies to optimize workflow and
 
 
 eliminate downtime and cost. A Continuous Improvement Engineer works across SQA&rsquo;s departments
 
 
 to foster a culture of innovation and efficiency within the organization.
 
 
 
 Primary Responsibilities
 
 
 
 <ul>
 <li>
 Support the Senior Technical Director and Field Engineering Director on finalizing scope of customer programs.
 </li>
 <li>
 Create/Configure customer program workbooks.
 </li>
 <li>
 Manage New Service Introduction and Launches
 </li>
 <li>
 Plan and Manage Pilot Program Launch and Monitoring
 </li>
 <li>
 Configure Training Guidelines for Program Resources
 </li>
 <li>
 Selection of Associates for Scoped programs
 </li>
 <li>
 Setup up Qualification Parameters for associates
 </li>
 <li>
 Set up internal improvement initiatives to reduce costs and increase margins of programs
 </li>
 <li>
 Manage Corrective and Preventive actions for customer complaints and internal audits
 </li>
 <li>
 Track and Review Program Technical Parameters and KPIs and remediate out of specification conditions
 </li>
 <li>
 Coordinate Validation of Programs and effectiveness checks, as well as report progress to Senior Technical Director
 </li>
 <li>
 Support risk management activities to formulate controls plans for customer programs
 </li>
 <li>
 Review and assist in writing new procedures and work instructions or updating existing documents for customer programs
 </li>
 <li>
 Participate in customer technical meetings and guide customers to SQA proposed solutions
 </li>
 <li>
 Shadow associates in the field as part of associate final qualification plans
 
 
 
 
 </li>
 </ul>
 
 Secondary Responsibilities:
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in engineering or related field from an accredited college or university
 </li>
 <li>
 3+ years&rsquo; experience in Quality Engineering, Manufacturing Engineering or Industrial Engineering
 </li>
 <li>
 Experience working in an industrial manufacturing environment
 </li>
 <li>
 Proficient in quality analysis tools such as 8D, SPC, PFMEA and others
 </li>
 <li>
 Six Sigma Black Belt
 </li>
 <li>
 Strong problem-solving skills with the ability to teach basic problem-solving techniques and facilitate problem solving team events
 </li>
 <li>
 Experience in developing part certification processes (PPAP) and vendor quality measures
 </li>
 <li>
 Knowledge of fabrication-based quality control methods, tools and techniques
 </li>
 <li>
 GD&amp;T proficiency, interpretation of drawings and measurement systems applicable to characteristic checks
 </li>
 <li>
 Strong engineering analysis skills, as well as data analysis and reporting
 </li>
 <li>
 Strong communication, presentation, and team building skills
 </li>
 <li>
 Manages time effectively, remains organized in all circumstances
 </li>
 <li>
 Self-motivated with a high level of initiative
 </li>
 <li>
 Must be able to travel to customer program sites and associate shadowing based on a planned schedule
 
 
 
 
 </li>
 </ul>
 
 Qualifications, Skills And Experience
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in engineering or related field from an accredited college or university.
 </li>
 <li>
 3+ years&rsquo; experience in Quality Engineering, Manufacturing Engineering, or Industrial Engineering
 </li>
 <li>
 Experience working in an industrial manufacturing environment.
 </li>
 <li>
 Proven experience in continuous improvement roles.
 </li>
 <li>
 Excellent project management and organization skills
 </li>
 <li>
 Ability to work collaboratively with cross-functional teams.
 </li>
 <li>
 Data-driven mindset with proficiency in data analysis tools such as 8D, SPC, PFMEA, and others. Lean Six Sigma Certified.
 </li>
 <li>
 Proficient problem-solving skills with the ability to teach basic problem-solving techniques and facilitate problem-solving team events.
 </li>
 <li>
 Strong engineering analysis skills
 </li>
 <li>
 Lead Auditor of Quality Management System experience.
 </li>
 <li>
 Experience in implementation and maintenance of ISO 9001, AS9001, ISO 13485, and other international quality requirements and standards
 </li>
 <li>
 Experience managing change control processes.
 </li>
 <li>
 Strong communication, presentation, and team building skills.
 </li>
 <li>
 Manages time effectively, remains organized in all circumstances
 </li>
 <li>
 Self-motivated with a high level of initiative
 </li>
 <li>
 Must be able to travel to customer program sites and associate shadowing based on a planned schedule.
 
 
 
 
 </li>
 </ul>
 
 Quality is SQA&rsquo;s culture and keeping the world safe is SQA&rsquo;s mission.
 
 SQA employees empower
 
 
 our partners with the expertise, professionals, and systems to proactively and predictively manage
 
 
 supply chain risks, creating safer and more reliable products for end users.
 
 
 SQA is an Equal Opportunity Employer; employment with us is governed based on merit, competence
 
 
 and qualifications and will not be influenced in any manner by race, color, religion, gender, national
 
 
 origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status,
 
 
 mental or physical disability or any other legally protected status.
 
 
 (*) To conform to U.S. Government export regulations, applicant must be a (i) U.S. citizen or national, (ii)
 
 
 U.S. lawful, permanent resident (aka green card holder), (iii) Refugee under 8 U.S.C.
 
 
 
 <ul>
 <li>
 1157, or (iv)
 
 
 
 
 </li>
 </ul>
 Asylee under 8 U.S.C.
 
 
 
 <ul>
 <li>
 1158, or be eligible to obtain the required authorizations from the U.S
 
 
 
 
 </li>
 </ul>
 Department of State. Learn more about the ITAR here
 
 
 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
 
 
 Your actual level and base salary will be determined on a case-by-case basis and may
 
 
 vary based on the following considerations: job-related knowledge and skills, education,
 
 
 and experience.
 
 
 Base salary is just one part of your total rewards package at SQA. You will also receive
 
 
 access to comprehensive medical, vision, and dental coverage, access to a 401(k)-
 
 
 retirement plan (after 1yr of employment), short and long-term disability insurance, life
 
 
 insurance, paid parental leave, and various other discounts and perks. You may also
 
 
 accrue 3 weeks of paid vacation and will be eligible for 8 or more paid holidays per year.
 
 
 Corporate employees are eligible for 5 days of sick leave per year.
</div>

Field Engineering Business Manager (Aerospace)

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