Computer Systems Validation Engineer
3 giorni fa
CAI is a 100% employee-owned company established in 1996, with over 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management, and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Our ApproachWe put the client's interests first, and we do not stop until it is right. We are committed to living our Foundational Principles, both professionally and personally:
- We act with integrity.
- We serve each other.
- We serve society.
- We work for our future.
We are seeking a Computer Systems Validation Engineer to develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person will be responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Position RequirementsThe ideal candidate will have:
- BS in a Computer Science or Engineering field or equivalent experience.
- 2-7 years' experience with Computer systems validation.
- 2 years' experience working in a GMP environment.
- Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired.
- Experience in biotech and pharma is preferred over medical device.
- Experience with MES, Delta V, PI is a plus.
We use all major systems, serving a multitude of clients. We invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
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