Computer Systems Validation Engineer
7 giorni fa
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 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 Approach
We put the client's interests first, and we do not stop until it is right. We will do whatever it takes to get there.
Our Foundational Principles
- We act with integrity.
- We serve each other.
- We serve society.
- We work for our future.
Position Description
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.
Position 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.
Other Requirements
- Excellent oral and written communication skills in English/Fluent in English.
- Able to travel domestically and internationally as required.
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