CSV Engineer
1 settimana fa
About CAI
We are a 100% employee-owned company established in 1996, with over 700 people worldwide, providing commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Our Approach
We put the client's interests first, and do not stop until it is right. We will do whatever it takes to get there.
Our Foundational Principles
We act with integrity, serve each other, serve society, and work for our future. As owners of CAI, we are committed to living these principles, both professionally and personally.
Our Core Values
We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude. This is how we have grown exponentially.
Position Overview
The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Key Responsibilities
- Develop and execute protocols and test scripts
- Identify gaps and consult on plans for resolution
- Write GxP computer validation and 21 CFR Part 11 related documentation
Requirements
- 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
Additional Requirements
- Excellent oral and written communication skills in English
- Able to travel domestically and internationally as required
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