Computer System Validation Engineer

Avantor is seeking a dedicated and innovative Computer System Validation Engineer to join our team on a full-time and remote basis.

In this role, you will be responsible for leading Computer System Validation projects related to our ERP System, manufacturing digitization, lab equipment, and proprietary laboratory information systems.

Working hours: regular European business hours

The team

You will join a global team of two other CSV engineers based out of Canada and the U.S. and take over European projects with the possibility of branching out to other regions in the future.

Who we are looking for

Education: Higher education in a technical field (preferred: IT, engineering, biotechnology, or related)

Experience:

• Ability to perform Computerized System Validation (CSV)
• Understanding of FDA, EU, and other regulatory requirements for system validation
• Experience with medical devices, pharma or biotech, and related regulations (GMP, GAMP-5, ISO standards, etc.)
• Working with cross-functional teams (IT, Quality, R&D, Engineering)
• IT infrastructure and qualification processes
• Internal and external audits (preferred)
• Professional proficiency in English

How you will thrive and create an impact

• Coordinate and lead CSV activities for computerized and automation systems for labs and manufacturing
• Act as Subject Matter Expert (SME) in CSV projects
• Collaborate with business teams to maintain and improve CSV processes
• Develop and monitor test scripts to assess system functionality, reliability, and quality
• Define CSV strategy and validation policy for current and future IT systems
• Participate in system implementation, maintenance, and retirement projects
• Review and approve validation documentation in line with procedures and regulations
• Deliver training on software validation and Part 11 requirements
• Support internal and external audits as CSV expert
• Monitor validation status and conduct periodic reviews of systems

Our offer to you

• Participation in Avantor’s discretionary bonus program
• Free Lux Med medical package with the option to include family members
• Multisport card / MyBenefit cafeteria with monthly employer contributions
• Access to group insurance on favorable terms
• Benefits from the Company Social Fund
• Employee referral program with attractive rewards
• Access to training via LinkedIn Learning and Rosetta Stone
• Supportive team and friendly work atmosphere

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.