system validation engineer

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain Engineering
Job Sub Function:
Automation Engineering
Job Category:
People Leader
All Job Posting Locations:
Wilson, North Carolina, United States of America
Job Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Ready to lead at the forefront of innovation? Learn more and apply today!
The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices. The incumbent is also accountable for the delivery and execution of the site&rsquo;s CSV strategy including projects and lifecycle management. The Manager Computer System Validation Engineer reports to the Site Sr. Manager Automation BioNC.
Execution Systems (ES) is a dedicated team of Automation professionals with various technical expertise, responsible for the implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility. Ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.
The new facility and the production process are envisioned to be highly automated with data being shared across multiple platforms to support production, from raw material receipt to disposition of the produced drug substance. Data generated at each stage of production will be shared across business information and control systems, including the multivariate analysis to support predicative models for process control and disposition support.
Key Responsibilities:<ul><li>
Support the automation systems, configure interfaces, ensure compliance with global standards, write, and perform validation protocols, participate in compliance inspections, hold and support risk assessments, and support investigations.</li><li>
Expert level knowledge of change management and change control of highly integrated recipe and OT Systems</li><li>
Ensure sound technical engineering concepts are applied in all tasks.</li><li>
Perform validation activities at the Site and ensure the approach and execution aligns to J&amp;J expectations. Scope includes OT, Execution Systems</li><li>
Understands industry-wide and Regulatory expectations for computer system validation and works with other members of OT and site organizations to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures.</li><li>
Provide input on improvement of life cycle documentation. Provide input on SOP development.</li><li>
Act as a high-level technical resource for implementation of policy in partnership with the quality organization(s) to ensure alignment in approach and desired acceptance criteria.</li><li>
Support the implementation and adoption of the global CSV program and remediation. Support data integrity implementation and remediation for systems within CSV program. Participate in continuous improvement efforts related to CSV program.</li><li>
Support the Execution Systems organization to achieve all CSV sites and corporate goals.</li><li>
Define Computerized Systems Validation scope and ensure resources, capabilities and processes are in place.</li><li>
Could lead improvement projects related to automation or computerized systems.</li><li>
Effective tracking cost, quality, and schedule to ensure effective management of project execution.</li><li>
Ensure programs stay on target through accurate resourcing and removing obstacles, which may involve communication at a senior level within the business and supporting partners (ie. Digital and Technical Operations and Systems (DOTS)).</li><li>
Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others by developing new partnerships to identify continuous improvement opportunities of site validation practices.</li><li>
Primary CSV point of contact at the site.</li><li>
Define, monitor and report metrics and KPI.</li><li>
Lead the CSV team to deliver on key projects and Lifecycle management.</li></ul>
Qualifications
Education:<ul><li>
A minimum Bachelor Degree and/or equivalent degree in Engineering; required</li></ul>
Experience and Skills:
Required:
<ul><li>Minimum 6+ years of experience in a biopharmaceutical or pharmaceutical GMP manufacturing environment, with direct accountability for computerized system validation (CSV) activities supporting regulatory compliance and inspection readiness; or an equivalent combination of education and experience.</li><li>
A minimum 2 years of proven experience in a GMP‑regulated Execution Systems, Automation, or IT role, including authoring, reviewing, and approving CSV lifecycle documentation used to support FDA, EMA, and other global regulatory inspections.</li><li>
In‑depth technical and validation expertise in automation platforms including Emerson DeltaV (including DeltaV Batch Control), OSIsoft PI, Siemens PLCs, and supporting IT infrastructure, with hands‑on responsibility for change control, impact assessment, and validation defense during audits.</li><li>
MES (preferably in Werum PAS-X) and DeltaV Batch Control experience.</li><li>
Knowledge of Industrial Automation Networks and their Communication Protocols.</li><li>
Good understanding of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses &amp; CDL.</li><li>
Good understanding of the ISA S95 &amp; S88 standards and how they should be used within the Global Supply Chain.</li><li>
Deep understanding of cGMP regulations related to CSV, including 21 CFR Part 11, EU GMP Annex 11, and data integrity principles (ALCOA+), applied in inspection‑ready validation strategies</li><li>
Experience in supervision/management of people and resources.</li><li>
Proven application of GAMP 5 methodologies, including risk‑based validation approaches, lifecycle documentation, and inspection‑defensible traceability across highly integrated OT and execution systems</li></ul>
Preferred:<ul><li>
Process knowledge for Upstream, Downstream and Bio Processing Support functions.</li></ul>
Other:<ul><li>
Ability to travel up to 10% of the time; international and domestic</li></ul>
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Artificial Intelligence (AI), Business Alignment, Data Integration, Developing Others, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Process Improvements, Prototyping, Quality Assurance (QA), Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Smart Systems, Team Management, Workflow Automation</div>

Manager Computer System Validation Engineer (CSV)

Sanofi

<div>Job Title: Validation Engineer &ndash; CSV (MES/ERP Focus)
Company: Sanofi &ndash; FLEXT Direct (Contingent Workforce Program)
Pay Range: $75.00 - $98.00 per hour
Location: Swiftwater, PA
Contract Duration: 12 Months
Position Overview
Sanofi&rsquo;s contingent workforce program, FLEXT Direct, is seeking an experienced Validation Engineer to support computerized system validation activities within a GMP-regulated pharmaceutical/biopharmaceutical manufacturing environment.
This role will focus heavily on validation of MES (Manufacturing Execution Systems), ERP systems, and computerized equipment, ensuring compliance with regulatory and quality standards.
Key Responsibilities<ul><li>
Lead and execute Computerized System Validation (CSV) lifecycle activities for MES, ERP, and related systems</li><li>
Develop and review validation documentation including URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports</li><li>
Support computerized equipment qualification efforts</li><li>
Ensure compliance with GMP, Quality System Regulations (QSR), and 21 CFR Part 11</li><li>
Lead and support CAPA (Corrective and Preventive Action) investigations and remediation activities</li><li>
Partner cross-functionally with Quality, Manufacturing, IT, and Engineering teams</li><li>
Manage multiple validation projects while meeting strict deadlines</li><li>
Maintain accurate and audit-ready documentation</li></ul>
Qualifications<ul><li>
Bachelor&rsquo;s degree in Engineering or related technical discipline required</li><li>
Master&rsquo;s degree preferred</li><li>
6&ndash;9 years of experience in pharmaceutical, biopharmaceutical, or regulated manufacturing environment</li><li>
Demonstrated experience validating MES and/or ERP systems</li><li>
Strong understanding of validation lifecycle principles and regulatory compliance requirements</li><li>
Experience leading or supporting CAPA activities</li><li>
Detail-oriented with strong organizational skills</li><li>
Ability to manage multiple projects concurrently</li><li>
Strong written and verbal communication skills</li></ul></div>

Validation Engineer (contract)

Dana

<div>Dana is a global leader in the supply of highly engineered driveline, sealing, and thermal-management technologies that improve the efficiency and performance of vehicles with both conventional and alternative-energy powertrains. Serving two primary markets &ndash; passenger vehicle and commercial truck &ndash; Dana provides the world's original-equipment manufacturers and the aftermarket with local product and service support through a network of nearly 100 engineering, manufacturing, and distribution facilities.<div><div><div><h2 class="jobSectionHeader">
Job Purpose</h2></div><div>
Dana is a global leader in the supply of highly engineered Software &amp; System, driveline, sealing, and thermal-management technologies that improve the efficiency and performance of vehicles with both conventional and alternative-energy powertrains. Serving two primary markets &ndash; Light vehicle and commercial truck&ndash; Dana provides the world&rsquo;s original equipment manufacturers and the aftermarket with local product and service support through a network of nearly 100 engineering, manufacturing, and distribution facilities.</div></div><div><div><h2 class="jobSectionHeader">
Job Duties and Responsibilities</h2></div><div><ul><li>
Analyze System and Software requirements, develop and execute test cases via physical Electrification Dynamometer according to system (V&amp;V) strategy and plan.</li><li>
Execute all system integration and qualification validation plans, support SW development debug, regression testing, &amp; bug fixes validation.</li><li>
Ensure bidirectional traceability from test case to Software and system requirements.</li><li>
Prepare and present SW V&amp;V reports and appropriate metrics per SW &amp; System V&amp;V strategy and plan.</li><li>
Ensure test cases are created/revised for the requirements called out in the current release plan.</li><li>
Support and align cross-functional teams in development, root cause analysis.</li><li>
Enter all noteworthy information into the test log program. (i.e. bench problems, hardware).</li><li>
Experience with accessing risks and validation needs of software products for Functional Safety and Cybersecurity and data integrity aspect.</li><li>
Attend meetings, coordinate tasks and communicate project planning status to stakeholders, managers, Leads, EPMs, and V&amp;V engineers.</li><li>
Collaborate with engineering programs team and participate in internally/externally customers technical discussion (Validation results, summary, final DVP &amp; R, Design Changes Request alignment internally/externally.</li><li>
Work with Process/Automation and HIL Commission teams to align timing and bench needed as required to perform V &amp; V related to Software Validation pertaining to the program milestones.</li><li>
Coordinating with the Continuous Improvement product owners.</li><li>
Performs various technical duties in support of research activities.</li><li>
Performs other related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Education and Qualifications</h2></div><div><ul><li>
1+ years of relevant working experience focus on power electrification embedded software and system validation</li><li>
Working Experience in Automotive Tools (VectorCast, Vector Canape, CANalyzer/CANoe, CANdella Studio, Typhoon, dSPACE, Automation Desk, Synect, Polarion, Jira, Azure Git).</li><li>
Knowledge of embedded C/C++ software and Model Based Embedded Software Design.</li><li>
Knowledge of SW testing methodologies (black box, grey box, interface testing, validation life cycle).</li><li>
ASPICE, ISO 26262, AUTOSAR, Cyber Security Testing Methods.</li><li>
Good analytical skills, curious, and autonomous and ability to work with multidisciplinary and global team.</li><li>
Rigorous and strong ability to meet deadlines.</li><li>
Commitment to the highest standards of ethical behavior in self and others; commitment to inclusion and diversity.</li></ul></div></div></div> 
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. 
Unsolicited Resumes from Third-Party Recruiters
 Please note that as per Dana policy, we do not accept unsolicited resumes from third-party recruiters unless such recruiters were engaged to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that Dana will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.</div>

System V&V Engineer

Micron Technology

<div>Our vision is to transform how the world uses information to enrich life for all.
Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever.
Join our forward-thinking engineering group at Micron, where you will have a key role in changing how the world accesses information. As a Staff Engineer for SSD Validation, you will coordinate the validation, system integration, and joint qualification of our elite Enterprise and Datacenter NVMe SSD products. This is your chance to contribute in a cooperative and welcoming setting while promoting technical excellence and innovation!
Position Overview
The Staff Engineer for SSD Validation directs the technical activities in validation, system integration, and collaborative qualification of Enterprise and Datacenter NVMe SSD products. This position oversees the validation strategy and actively engages in firmware, hardware, and system testing. It holds primary responsibility for assisting new customers through joint qualification (JQ). The Staff Engineer serves as a specialist in NVMe/PCIe, encourages automation and early quality improvements, and mentors other engineers. They also guarantee that products are prepared for production on both internal and customer platforms. Working with Firmware, Hardware, Product Engineering, Manufacturing, and Customer Engineering teams, this role fosters internal coordination and uniform qualification outcomes.
Responsibilities<ul><li>
Lead system-level validation and qualification, performing end-to-end testing across SSDs, firmware, drivers, OS, networking, and platform configurations.</li><li>
Direct validation test plans from development through completion, including failure analysis, reporting, and coordination with customer joint qualification (JQ) requirements.</li><li>
Perform hands-on system bring-up, debug, and configuration, including OS installation, driver validation, and storage-stack verification.</li><li>
Support customer and partner issue reproduction, converting field/JQ findings into internal test cases and improving validation coverage.</li><li>
Develop and improve automated test frameworks and Python-based tools while driving shift-left validation to influence build and improve product testability.</li></ul>
Minimum Qualifications<ul><li>
Bachelor&rsquo;s degree in Electrical/Computer Engineering, Computer Science, or related field</li><li>
5+ years of experience in SSD, storage, or semiconductor validation with deep knowledge of NVMe and PCIe protocols</li><li>
Hands-on expertise with Linux environments, system setup, OS bring-up, drive triage, and root-cause analysis of complex issues</li><li>
Proven background in Enterprise/Datacenter SSD firmware validation, including system-level joint qualification</li><li>
Proficiency in Python for automation and data analysis, paired with strong communication skills for conveying technical results to internal and external partners</li></ul>
Preferred Qualifications<ul><li>
Experience leading or assisting customer joint qualification (JQ) efforts with OEMs, hyperscalers, or strategic partners</li><li>
Familiarity with networked storage environments, platform interoperability, and multi-system qualification flows</li><li>
Hands-on experience with protocol analyzers (e.g., Lecroy, JDSU) and third-party SSD test platforms (e.g., UNH-IOL, PCI-SIG compliance, SanBlaze)</li><li>
Strong understanding of PCIe topology, BIOS/firmware behavior, Linux storage stacks, and drivers</li><li>
Knowledge of NAND flash, storage architecture, and FTL development</li></ul>
The US base salary range that Micron Technology estimates it could pay for this full-time position is:
$135,000.00 - $286,000.00 a year
Additional compensation may include benefits, bonuses and equity. 
Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target base pay for new hire salaries of the position across all US locations. Within the range, individual pay is determined by work location and additional job-related factors, including knowledge, skills, experience, tenure and relevant education or training. The pay scale is subject to change depending on business needs. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. 
 
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
As a world leader in the semiconductor industry, Micron is dedicated to your personal wellbeing and professional growth. Micron benefits are designed to help you stay well, provide peace of mind and help you prepare for the future. We offer a choice of medical, dental and vision plans in all locations enabling team members to select the plans that best meet their family healthcare needs and budget. Micron also provides benefit programs that help protect your income if you are unable to work due to illness or injury, and paid family leave. Additionally, Micron benefits include a robust paid time-off program and paid holidays. For additional information regarding the Benefit programs available, please see the Benefits Guide posted on micron.com/careers/benefits.
Micron is proud to be an equal opportunity workplace and is an affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, citizenship status, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws. 
To learn more about Micron, please visit micron.com/careers
US Sites Only: To request assistance with the application process and/or for reasonable accommodations, please contact Micron&rsquo;s People Organization at hrsupport_na@micron.com or 1-800-336-8918 (select option #3)
Micron Prohibits the use of child labor and complies with all applicable laws, rules, regulations, and other international and industry labor standards.
Micron does not charge candidates any recruitment fees or unlawfully collect any other payment from candidates as consideration for their employment with Micron.
AI alert: Candidates are encouraged to use AI tools to enhance their resume and/or application materials. However, all information provided must be accurate and reflect the candidate's true skills and experiences. Misuse of AI to fabricate or misrepresent qualifications will result in immediate disqualification.
Fraud alert: Micron advises job seekers to be cautious of unsolicited job offers and to verify the authenticity of any communication claiming to be from Micron by checking the official Micron careers website in the About Micron Technology, Inc.</div>

Staff Engineer, SSD Validation

PQE Group

<div>
 
 Are you ready to join a
 
 world leader
 
 in the exciting and dynamic fields of the
 
 Pharmaceutical and Medical Device industries
 
 ?
 
 PQE Group
 
 has been at the forefront of these industries
 
 since 1998
 
 , with
 
 40 subsidiaries
 
 and more than
 
 2000 employees in Europe, Asia and the Americas
 
 .
 
 
 
 
 
 Following a new opportunity, we are currently looking for a
 
 CSV Engineer - Pharma sector (FREELANCERS ONLY)
 
 
 
 with a strong background in regulated industrial environments, ideally within pharmaceutical, biotech or life sciences manufacturing, to support our projects in
 
 Cairo
 
 , Egypt
 
 .
 
 
 
 
 
 
 
 
 
 
 
 You&rsquo;ll be responsible for
 
 :
 
 
 
 
 
 <ul>
 <li>
 Reviewing existing validation documentation and GAP assessment findings
 </li>
 <li>
 Developing compliance documents to close gaps without full re-validation
 </li>
 <li>
 Prioritizing remediation activities across 61 systems (GAMP 3&ndash;5)
 </li>
 <li>
 Managing remediation tracker and reporting progress
 </li>
 <li>
 Supporting validation for manufacturing, packaging, and lab systems
 </li>
 <li>
 Assessing data integrity and 21 CFR Part 11 compliance
 </li>
 <li>
 Applying a risk-based approach to gap closure and updating risk assessments
 </li>
 <li>
 Coordinating with cross-functional teams and vendors
 </li>
 </ul>
 
 
 
 
 
 
 
 
 
 About you:
 
 
 
 
 
 
 <ul>
 <li>
 Minimum
 
 7 years of experience
 
 in Computer System Validation within the pharmaceutical industry
 </li>
 <li>
 Deep knowledge of
 
 GxP regulations
 
 (GMP, 21 CFR Part 11, EU Annex 11)
 </li>
 <li>
 Experience with
 
 multi-system GAP remediation programs
 
 </li>
 <li>
 Strong documentation and project management skills
 </li>
 <li>
 Ability to work independently as a
 
 freelancer/contractor
 
 </li>
 <li>
 Excellent communication and collaboration skills in a regulated environment
 </li>
 </ul>
 
 
 
 
 
 
 
 
 
 Availability
 
 
 : 100% on site
 
 
 
 
 Location
 
 
 : Cairo, Egypt
 
 
 
 
 Duration of the project
 
 
 : up to 1 year
 
 
 
 
 
 
 
 
 
 Next Steps
 
 
 
 Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
 
 
 If there's a positive match, a technical interview with the Hiring Manager will be arranged.
 
 
 In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
 
 
 Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
 
 
 
 
 
 
 
 
 
 Working at PQE Group
 
 
 
 As a member of the PQE team, you will be part of a
 
 challenging, multicultural company that values collaboration and innovation
 
 . PQE Group gives you the
 
 opportunity to work on international projects
 
 , improve your skills and interact with colleagues from all corners of the world. If you are looking for a
 
 rewarding and exciting career
 
 , PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
 
 
 
</div>

Senior CSV Engineer (Contract/Freelance)

Hardware System Validation Lead

Tolmar

<div>Core Hours

Monday - Friday, 8:00 am - 5:00 pm

Purpose and Scope

The Instrument and CSV Engineer I supports laboratory instruments and computer systems validation activities under general supervision. This role focuses on documentation, protocol execution, and learning regulatory expectations.

Essential Duties &amp; Responsibilities
<ul>
<li>Assist in developing and executing validation deliverables (IQ/OQ/PQ) for lab instruments and GxP computer systems including upgrades and revalidation.</li>
<li>Work with instrumentation and computer system vendors to verify validation criteria and data integrity requirements are met.</li>
<li>Support data collection, deviation documentation, and report generation for the Validation team.</li>
<li>Follow established procedures and templates for validation deliverables.</li>
<li>Complete assigned change actions for validation projects within defined timeframes.</li>
<li>Participate in instrument and system testing and verification activities.</li>
<li>Collaborate with QA, laboratory staff and IT to ensure compliance with 21 CFR Part 11 and data integrity and regulatory standards.</li>
<li>Adheres to company and departmental timelines with high accuracy and quality.</li>
<li>Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers.</li>
<li>Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.</li>
<li>Perform other duties as assigned.</li>
</ul>
Core Values

This position is expected to operate within the framework of Tolmar&rsquo;s Core Values:
<ul>
<li>Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
</li><li>Are Proactive &amp; Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
</li><li>Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion &amp; sustainability in our workplace.</li>
<li>Constantly Improve:We are committed to a collaborative &amp; proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency &amp; improving quality.
</li><li>Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability &amp; ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
</li></ul>Knowledge, Skills &amp; Abilities
<ul>
<li>Knowledge of software administration, user account creation, and computer system validation.</li>
<li>Effective oral and written communication skills.</li>
<li>Ability to work both independently and as part of a cross-functional team.</li>
<li>Knowledge of CSV/CSA principles, cGMP practices, regulatory and ICH guidelines.</li>
<li>Knowledge of Microsoft Office Suite, and various GxP software packages.</li>
<li>Knowledge of database design and maintenance, and laboratory software programs.</li>
<li>Ability to troubleshoot and implement problem-solving skills.</li>
<li>Ability to manage multiple projects concurrently and under tight time constraints.</li>
<li>Ability to adapt to shifting priorities and operate with a sense of urgency while maintaining high quality.</li>
</ul>
Education &amp; Experience
<ul>
<li>Bachelor&rsquo;s degree required, preferably in Computer Science, Engineering, and/or Life Sciences.</li>
<li>Some experience with software applications and/or in an analytical laboratory.</li>
<li>Knowledge of software administration, user account creation and maintenance, and computer system validation.</li>
<li>Experience with validation computer systems gained through formal academic studies or work experience.</li>
</ul>
Working Conditions
<ul>
<li>Working conditions include general office environment, and laboratory settings; will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.</li>
<li>Business demands may require working extended hours.</li>
</ul>
Compensation and Benefits
<ul>
<li>Pay: $70,000 - $75,000 depending on experience</li>
<li>Benefits summary: https://www.tolmar.com/careers/employee-benefits</li>
</ul>
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.</div>

Instrument and CSV Engineer I

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