
Validating Complex Systems
1 week ago
We're looking for a skilled system validation engineer to ensure the integrity and accuracy of our computer systems in a regulated environment.
Main Responsibilities:- Develop and execute validation protocols for computer systems, ensuring compliance with regulations and industry standards.
- Maintain knowledge of FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Collaborate with cross-functional teams to integrate computer system validation into manufacturing processes.
- Develop clear, concise reports on validation activities and results.
- Bachelor's degree in a related field or equivalent.
- 5-8 years experience in Computer System Validation/Quality Compliance in a FDA Regulated industry.
- Strong knowledge of cGMP concepts and FDA/EMA regulations.
- Hands-on experience in EDMS & Test Management tools.
- Ability to work on complex projects with general direction.
- Excellent written and oral communication skills.
- Knowledge of recent FDA guidance on transition of CSV to CSA.
- Understanding of process validation, computer and equipment validation, and GMPs.
We offer a dynamic work environment that encourages growth and development. If you're passionate about ensuring system quality, we encourage you to apply.
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