manufacturing engineer Jobs in Indianapolis

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manufacturing engineer/sr. manufacturing engineer - controls Jobs in Indianapolis

manufacturing engineer/sr. manufacturing engineer - controls

process engineer - indy device manufacturing Jobs in Indianapolis

process engineer - indy device manufacturing

supply chain industrial engineer Jobs in Indianapolis

supply chain industrial engineer

manufacturing engineer sr manufacturing engineer controls

Roche

<div>
 At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
 
 
 The Position
 
 
 Doing now what patients need next. Near Patient Care is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night. We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.
 
 
 Internal Manufacturing Indianapolis is a function within Roche Diagnostics - Near Patient Care Operations, responsible for the strip manufacturing of the majority of our blood glucose monitoring portfolio for the global demand of our patients. In the future, Internal Manufacturing Indianapolis will also be responsible for sensor manufacturing for our continuous glucose monitoring portfolio.
 
 
 
 The Opportunity:
 
 
 
 As a Manufacturing Engineer - Controls, you will provide technical engineering support of automated and semi-automated manufacturing equipment as required by the production schedule. You will troubleshoot equipment and process issues, lead/contribute to process improvement/characterization projects, train maintenance and production personnel, conduct pilot and validation activities following Roche Diagnostics &ndash; Near Patient Care Operations policies and procedure. You will ensure the validated state of the production process/equipment is maintained.
 
 
 
 Your Responsibilities;
 
 
 
 <ul>
 <li>
 Leads the development, implementation and maintenance of manufacturing methods, procedures and processes in the manufacture of products, components, subassemblies and final assemblies
 </li>
 <li>
 Develops and improves automation and electromechanical processes by studying requirements; researching and testing manufacturing and assembly methods and materials; and soliciting observations from operators and maintenance technicians
 </li>
 <li>
 Interfaces with design and process development engineering in coordinating the release of new products to the manufacturing process.
 </li>
 <li>
 Helps to estimate manufacturing cost and makes recommendations for tooling, controls system hardware and software, and process requirements of new or existing production lines
 </li>
 <li>
 Manages multiple projects and time scopes for each project
 </li>
 <li>
 Ensures process changes are characterized and implemented following validation policies and procedures
 </li>
 <li>
 Assures system and product quality by designing testing methods; testing finished -product and system capabilities; and confirming fabrication, assembly, and installation processes
 </li>
 <li>
 Assists department leadership in setting strategic direction
 </li>
 <li>
 Possess and apply a broad knowledge of principles, practices, and procedures of the field
 </li>
 <li>
 Maintains product and company reputation by complying with government regulations
 </li>
 <li>
 Provide guidance and advice to lower level staff
 </li>
 <li>
 Participates in the on-call rotation to provide off shift / weekend support to production, as needed
 </li>
 <li>
 Support key initiatives such as information management, cyber security, and life cycle management
 
 
 
 </li>
 </ul>
 
 Knowledge/Skills/Attributes
 
 
 <ul>
 <li>
 This role requires hands-on experience in troubleshooting manufacturing equipment controls systems. Key areas of focus include, but are not limited to:
 </li>
 <ul>
 <li>
 Electrical systems
 </li>
 <li>
 PLC ladder logic and structured text (preferably Allen Bradley PLCs using RSLogix/Studio 5000)
 </li>
 <li>
 Motion Controls (e.g. VFDs, servos, etc.)
 </li>
 <li>
 Human Machine Interface (HMI) (preferably FactoryTalk View SE/ME)
 </li>
 <li>
 Vision Inspection (preferably Cognex Insight Explorer)
 </li>
 <li>
 Distributed I/O (preferably Profibus/Ethernet IP)
 </li>
 <li>
 Sensors (e.g. part presence/absence, position, process monitoring, etc.)
 </li>
 </ul>
 <li>
 Comfortable modifying control system programs, configurations, and electrical systems to support continuous improvement activity
 </li>
 <li>
 Skilled in working with vendors to identify improvement project solutions and obsolete components replacements
 </li>
 <li>
 Experienced in developing and executing equipment qualification requirements, testing, and documentation
 </li>
 <li>
 Experienced in collaborating with teams to implement improvements, qualify changes, and resolve quality/downtime issues
 </li>
 <li>
 Seasoned, experienced professional with a full understanding of areas of specialization
 </li>
 <li>
 Ability to run simulations and analyze test data
 </li>
 <li>
 Ability to write and present clear and comprehensive technical documentation
 </li>
 <li>
 Highly analytical mind, with exceptional problem-solving skills and attention to detail
 
 
 </li>
 </ul>
 
 Who You Are
 
 
 <ul>
 <li>
 Manufacturing Engineer - Controls
 </li>
 <ul>
 <li>
 Bachelor&rsquo;s degree in Engineering or closely related discipline with 2 years of related experience; advanced degree may substitute for previous experience or equivalent experience
 </li>
 <li>
 Related experience must include troubleshooting, modifying, and/or developing industrial equipment controls systems (PLCs, HMIs, Motion Control, etc.)
 </li>
 </ul>
 <li>
 Sr. Manufacturing Engineer - Controls
 </li>
 <ul>
 <li>
 Bachelor&rsquo;s degree in Engineering or closely related discipline with 5 years relevant experience or Master&rsquo;s of Engineering/PhD with 2 years relevant experience or equivalent experience
 </li>
 <li>
 Relevant experience must include troubleshooting, modifying, and/or developing industrial equipment controls systems (PLCs, HMIs, Motion Control, etc.)
 
 </li>
 </ul>
 </ul>
 
 Preferences
 
 
 
 <ul>
 <li>
 Familiar with GMP in a regulated environment (Medical Device or Pharmaceutical)
 </li>
 <li>
 Previous experience troubleshooting controls systems of high volume/speed manufacturing equipment
 </li>
 <li>
 Previous training or experience in Process Improvement Methodologies (e.g. LSS, PDCA, etc.)
 </li>
 <li>
 Demonstrates excellent interpersonal, communication, and teamwork skills
 </li>
 <li>
 Strong ability to teach and educate key stakeholders and other colleagues
 </li>
 <li>
 Deep commitment to cross-functional collaboration and breaking down silos to achieve the best results for the organization
 
 
 </li>
 </ul>
 
 This is an onsite role in Indianapolis. Relocation benefits are not available.
 
 
 
 The expected salary range for the Manufacturing Engineer position based on the primary location of Indiana is $68,800 - $127,800 Annual. Actual pay will be determined based on experience, qualifications and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program. This position also qualifies for the benefits detailed at the link provided below.
 
 
 The expected salary range for the Senior Manufacturing Engineer position based on the primary location of Indiana is $83,200 - $154,500 Annual. Actual pay will be determined based on experience, qualifications and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program. This position also qualifies for the benefits detailed at the link provided below.
 
 
 Who we are
 
 
 A healthier future drives us to innovate. Together, more than 100&rsquo;000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
 
 
 Let&rsquo;s build a healthier future, together.
 
 
 Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
 
 
 If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
 
 
 Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
</div>

Manufacturing Engineer/Sr. Manufacturing Engineer - Controls

Jobot

<div>
 Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!
 
 
 Job details
 
 
 
 Manufacturing Engineer - Excellent Benefits + Perm/FT Employment w/ a growing company
 
 
 
 This Jobot Job is hosted by Dallas Gillespie
 
 
 Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
 
 
 Salary $80,000 - $110,000 per year
 
 
 
 A Bit About Us
 
 
 
 We are a large, rapidly growing EPC company known for being an employee-centric organization.
 
 
 
 
 
 
 Why join us?
 
 
 
 
 
 
 Great Benefits And Strong Compensation With Permanent/Full-time Employment.
 
 
 
 Career Advancement Opportunities
 
 
 Minimal Travel (0-5%)
 
 
 
 Job Details
 
 
 
 Position Title Manufacturing Engineer
 
 
 Position Summary
 
 
 The Manufacturing Engineer is responsible for improving, maintaining, and supporting manufacturing operations through process design, layout development, and equipment optimization. This role focuses on enhancing production efficiency, ensuring workplace safety, and maintaining compliance with company and regulatory standards. The position requires strong analytical and problem-solving skills, as well as hands-on experience with manufacturing processes, facility layouts, and continuous improvement initiatives.
 
 
 
 Minimum Qualifications
 
 
 
 Education
 
 
 Bachelor&rsquo;s degree in Manufacturing Engineering, Industrial Engineering, or a closely related discipline.
 
 
 
 Experience
 
 
 
 3 to 5 years of relevant experience within a manufacturing or industrial engineering environment is ideal for this role.
 
 
 Travel
 
 
 Occasional travel may be required, approximately 5% of the time.
 
 
 Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
 
 
 Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot&rsquo;s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
 
 
 Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
 
 
 Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
 
 
 By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here jobot.com/privacy-policy
 
 
 
 Want to learn more about this role and Jobot?
 
 
 
 Click our Jobot logo and follow our LinkedIn page!
 
 
</div>

Manufacturing Engineer

Activ8 Chicago

A global manufacturing company is looking for a Japanese Bilingual Electrical Engineer candidate in the Indianapolis area.Japanese Bilingual Electrical Engineer Responsibilities <ul><li>Designing, maintaining and improving control systems or electrical instruments</li><li>Testing and modifying existing systems</li><li>PLC programming and troubleshooting</li><li>Review electrical and mechanical project designs</li><li>Continuous improvement by developing new processes and equipment technology</li><li>Perform tests on machinery to ensure quality and performance standard compliance</li><li>Ensure that installation and operations conform to standards and customer requirements</li><li>Writing reports and compiling data regarding electrical engineering projects</li><li>Other duties as assigned</li></ul>Japanese Bilingual Electrical Engineer Responsibilities <ul><li>Associate or Bachelor&rsquo;s degree or equivalent experience</li><li>3 years' robotic programming experience in manufacturing industry</li><li>Strong experience with PLC or HMI</li><li>Ability to multi-task, prioritize tasks, and adapt to pressure</li><li>Ability to collaborate with other departments and colleagues</li><li>Able to communicate fluently in both written and verbal English</li><li>Able to lift up to 30 lbs</li><li>Direct applicants only</li></ul>Activ8 Recruitment &amp; Solutions / Renaissance Resources Inc. has been a trusted leader in North American recruiting for Japanese businesses for over 25 years. We specialize in connecting top talent with companies in the Automotive, Electronics, Food &amp; Beverage, Logistics, Manufacturing, Oil &amp; Gas, Banking &amp; Finance, and Entertainment industries. Our client-focused approach ensures that we understand your unique needs, whether you&rsquo;re a company seeking skilled professionals or candidate looking for the right career opportunity. By working closely with each individual, we provide tailored solutions that drive success.&#8239;We screen ALL Candidates to verify the validity of each applicant's provided information. Upon submitting your resume, we will contact only those candidates that we deem qualified for our client. If we do not contact you, we do not see the fit for the position. If we are unable to reach you in a reasonable timeframe, you will be eliminated from the pool of potential candidates.We prioritize direct applicants; third-party resumes may not be reviewed.Job Type: Full-timePay: $80,000.00 - $120,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Experience:<ul><li>Electrical engineering: 3 years (Preferred)</li></ul>Language:<ul><li>Japanese (Required)</li></ul>Work Location: In person

Japanese Bilingual Electrical Engineer - Automotive Parts (35795)

Thomas & Skinner, Inc.

Thomas &amp; Skinner is the world's leading manufacturer of cast and sintered Alnico magnets, magnetic assemblies and transformer laminations. Our 100% employee-owned company is involved in aerospace, industrial, defense, and oil exploration markets.We offer a comprehensive salary and benefit package including ESOP shares and 401(k) match.Candidates must be a U.S. Citizen Excellent opportunity for a Manufacturing Engineer with 3-5 years experience in an AS9100, TS or ISO quality system. If your looking to develop in to a leadership role, put your proven record of driving improvement projects to work in a hands-on environment. Experience in lean manufacturing, cost estimation, defining process instructions, machining, fixturing, CAD, GD&amp;T and inspection is a plus.<ul><li>Coordinate the mfg. launch of new/revised products including establishing goals, training team members and evaluating results.</li><li>Must have a BS degree in Mechanical Engineering or related field</li><li>Performs product/process analysis</li><li>Prepares detailed blueprints</li><li>Prepares and maintains process routers and bill of materials</li><li>Pattern, die, fixture design</li><li>Provide Shop floor support</li><li>Performs research design and development of manufacturing processes including production flow, assembly methods and production equipment.</li></ul>Job Type: Full-timeWork Location: In person

Eli Lilly

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
Position Brand Description:
Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune five hundred company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.
Lilly is at a critical juncture as we tool up to realize the potential of our product pipeline. We are building new processing capabilities around the world, and emphasizing emerging, innovative processing technologies, such as continuous processing and advanced biotech platforms. Lilly is in the process of expanding manufacturing with three new sites in Lebanon, Indiana and recent acquisition and expansion at Kenosha, Wisconsin. In addition, Lilly announced that four new pharmaceutical manufacturing sites would be built in the United States that includes both active pharmaceutical ingredients (API) and parenteral manufacturing for future injectable therapies (Drug Product). This role will focus on a parenteral manufacturing for future injectable therapies (Drug Product) site.
The Corporate Automation Project Engineer is a senior automation position that will lead the automation design and delivery to major capital projects and corporate initiatives with a focus on the Global Parenteral Network and the Global Packaging Network. This role is intended to lead one or more project workstreams for the design and delivery of Automation platforms for key parenteral systems including filling, formulation, equipment preparation, labs, and associated integration with IT platforms with a strong focus on Rockwell Automation based embedded and OEM provided solutions. This role will partner with A&amp;E firms and other Lilly consultants to develop conceptual, basic, and detailed design packages. The role will also collaborate with selected suppliers on build, FAT, and site startup activities.
This role will be part of Lilly&rsquo;s Global Process Automation &amp; Control Engineering (GPACE) team in Corporate Engineering. GPACE provides automation, measurement, and process control solutions. GPACE is a technical resource for training, standards, capital project delivery, and Lilly&rsquo;s standard automation platforms. GPACE&rsquo;s primary customers are global manufacturing and development sites, Corporate IT, and peer groups such as Global Facilities Delivery (GFD).
The Corporate Automation Project Engineer role requires a 4-year engineering degree or related science field. The candidate will need to be flexible on location and have the ability to travel both US and OUS.
Key Objectives/Deliverables<ul><li>
Be a champion for health &amp; safety, diversity &amp; inclusion, ethics, and compliance.</li><li>
Partner with Global Facilities Delivery, Global Groups, OEM&rsquo;s, Engineering firms, and site teams to design, install, and qualify key site parenteral platforms including autoclaves, freeze dryers, formulation units, filling lines, and inspection machines.</li><li>
Lead and support the development of statements of work and automation supplier and integrator selection.</li><li>
Lead and support delivery strategies, quality assessments, and CSV and C&amp;Q verification plans.</li><li>
Collaborate with site automation leadership to integrate resources into the project team. Assist with site hiring and capability building. Collaborate with other corporate engineering groups and Lilly IT to develop delivery strategies and execution plans.</li><li>
Coach and mentor others.</li></ul>
Basic Requirements:<ul><li>
Bachelor's in Engineering (preferably Electrical, Mechanical, Computer, or Chemical)</li><li>
Experience in pharmaceutical manufacturing.</li><li>
Experience on Rockwell Automation Platforms including FT View and Control Logix platforms</li><li>
Minimum 3 years of Process Automation / Process Control experience.</li><li>
Experience in Commissioning and Qualification</li></ul>
Additional Preferences:<ul><li>
Excellent verbal and written communications skills.</li><li>
Strong analytical and critical thinking skills.</li><li>
Collaborative skills with operations, process engineering, and other project &amp; manufacturing team members.</li><li>
Integration of OT and IT platforms.</li><li>
Project management experience.</li><li>
Technical knowledge in process instrumentation.</li><li>
Ability to influence without authority.</li><li>
Ability to clarify and simplify complex issues.</li><li>
Strong trust building with peers and leaders.</li><li>
Knowledge of GMP&rsquo;s and pharmaceutical manufacturing, preferably Drug Product Aseptic Filling, Formulation, or Lyophilization.</li><li>
Knowledge in Microsoft Operating Systems</li><li>
Knowledge in Databases</li></ul>
Other Information:
The Project Engineer role will initially start out in Indianapolis, IN but will transition full time to a project site location once determined. During or after completion of this project, it is possible that this role will transition to a permanent site role.
There can be some accommodation for remote work until the project location is determined. There will also be project travel (would not typically exceed 25%) associated with the role, both US and OUS to support design reviews, FAT&rsquo;s, and other project related activities.
8-hour days - Monday through Friday, overtime and some weekend/holiday may be required for project support.
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&rsquo;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&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Corporate Automation Project Engineer - Drug Product

Binding Minds, LLP

Qualifications<ul><li>Associate&rsquo;s degree or equivalent advanced education or training.</li><li>Strong knowledge of manufacturing operations, quality, and supplier quality management (preferred).</li><li>Experience with SAP, TrackWise, and Veeva QualityDocs (preferred).</li><li>Experience in Change Management.</li><li>High proficiency with MS Office (Teams, OneNote, OneDrive, SharePoint, PowerPoint, Excel).</li><li>Proven ability to communicate and deliver constructive feedback, with strong interpersonal, oral presentation, and written communication skills.</li><li>Demonstrated creativity in strategy development and problem solving.</li><li>Ability to work both independently and collaboratively with minimal supervision.</li><li>Ability to communicate, influence, and train effectively.</li></ul>Additional Skills/Preferences<ul><li>Minimum of five (5) years of experience at a manufacturing site within a QA organization.</li><li>Strong knowledge of quality management, supplier quality management, ISO, and GMPs.</li><li>Experience with PowerApps, Power BI, Tableau.</li><li>Familiarity with GQS, CQP, LQP.</li><li>Proficient English oral and written communication.</li><li>Ability to travel to manufacturing sites as required.</li></ul>ResponsibilitiesThe Quality Control Representative is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of new site expansions. The role ensures effective and timely onboarding of suppliers, materials, and GMP service providers to support supply chain and affiliate project timelines. This position partners closely with cross-functional business teams to ensure consistent implementation across networks and functions.The GSQM program promotes a globally consistent and holistic approach to GMP supplier and GMP service provider management, ensuring strong compliance, patient safety, product quality, and robust technical standards.Key Objectives / DeliverablesActivities will be performed according to established procedures, guidelines, forms, and tools. Responsibilities include, but are not limited to:<ul><li>Execute supplier quality management processes in accordance with Global Quality Standards (GQS305, GQS301, GQS307, and others as applicable).</li><li>Support procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing teams in identifying and managing material suppliers and GMP service providers.</li><li>Perform SAP and TW138 activities related to the Approved Supplier List (ASL) on behalf of site expansions; collaborate with SAP Business QA as needed.</li><li>Coordinate with manufacturing and affiliate sites across the network (API, Manufacturing, Packaging, DPEM, APIEM, Devices) to ensure robust and effective process execution, escalating barriers where necessary.</li><li>Develop and communicate processes associated with the GSQM program and related initiatives.</li><li>Support the maintenance of supplier quality management data, including approved supplier and GMP service provider lists, in systems such as SAP, VeevaVault (QDocs), and TrackWise.</li><li>Assist with Certification Package Review Boards and global certification packages for SAP Manufacturing Plants (MPs) materials.</li><li>Collaborate with Global TS/MS to execute material risk control strategies, including material risk, product acceptance risk, and specification controls.</li><li>Provide input and support for supplier-related change controls.</li></ul>This role requires maintaining comprehensive knowledge of applicable regulations, technical requirements, and training to fulfill these responsibilities.Personal Development<ul><li>Stay current on industry trends and regulatory interpretations of GMP/cGMP requirements, especially those related to Supplier Management Programs.</li><li>Maintain strong interpersonal, verbal, and technical writing skills.</li><li>Complete required training and qualifications outlined in the Learning Plan (LP).</li></ul>Comments / Special Instructions This is an onsite position.Job Type: ContractPay: $36.00 - $38.35 per hourWork Location: In person

Quality Control Representative

<div>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&rsquo;re looking for people who are determined to make life better for people around the world.
Position Title: Process Engineer &ndash; Indy Device Manufacturing
Job Level: P1 &ndash; P4
Functional Unit: Engineering
Supervisor Title: Manager, Process Engineering &ndash; Indy Device Manufacturing (IDM)
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
The position is responsible for working with Contract Manufacturer(s) (CM) and Original Equipment Manufacturer (OEM) to support, supply, quality, and continuous process improvement of delivery devices, sub-assemblies, and components that are supplied to Lilly packaging and manufacturing sites.
Responsibilites:<ul><li>
Provide technical oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.</li><li>
Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability</li><li>
Support all aspects of tool and process validations including computer system validation. Includes creation, execution and coordination of validation activities in partnership with Contract Manufacturers.</li><li>
Manage the generation rationalization of user requirements for each project</li><li>
Define and mitigate technical and patient risks, including use of FMEA</li><li>
Assure each design includes maximum appropriate re-use of technology from prior projects</li><li>
Oversee OEM's design process, assuring questions are resolved and barriers to progress are removed</li><li>
Conduct thorough design reviews to assure design meets requirements and local/corporate standards</li><li>
Characterize unit operations and set operating conditions as required by defining an Engineering Studies plan, developing rigorous studies and executing them</li><li>
Assure testing is appropriately developed and is in accordance with the risk level of the item being tested</li><li>
Document research and investigations as technical reports</li><li>
Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab based testing, documentation of the data and completion of technical reports.</li><li>
Work with external companies and project teams to develop product and process improvements.</li><li>
Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.</li><li>
Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.</li><li>
Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.</li><li>
Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.</li><li>
Participate on Commercialization project teams for new devices with focus on manufacturing readiness.
</li><li>Ensure timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.</li><li>
Lead prioritization of process and product changes necessary to maintain, sustain and improve the manufacturing process.</li><li>
Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.</li><li>
Develop effective and productive working relationships with colleagues at CM sites.</li><li>
Lead cross-functional/cross-site/cross-company project teams as needed.</li><li>
Influence Commercialization project teams for new devices with focus on manufacturing readiness.</li><li>
Identify and implement process and product changes necessary to maintain, sustain and improve the manufacturing process.</li><li>
Support Technical Stewardship projects to improve device design.</li><li>
Develop effective and productive working relationships with colleagues at CM sites.</li></ul> 
Minimum Requirements:<ul><li>
Minimum 2 years engineering experience, preferably in Manufacturing</li><li>
BS in an Engineering or Engineering related field</li><li>
Demonstrated high degree of ownership / accountability</li><li>
Strong communication, teamwork, and networking skills</li><li>
Mechanical Aptitude</li><li>
Solid technical writing skills</li><li>
Proven ability to organize and prioritize multiple tasks</li><li>
Strong attention to detail</li><li>
Proven problem solving skills</li><li>
Ability to work independently as well as in a team environment</li></ul> 
Additional Preferences:<ul><li>
Medical Devices experiences preferred</li><li>
Experience with DOE and statistical methods as applied to engineering studies and reports</li><li>
Experience in large capital project delivery and management of sub-projects within a larger project</li></ul>
Additional Information:
<ul><li>Ability to travel 25% on average with peak over 50% for a few months at a time</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&rsquo;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&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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