Job Information
Astrix Technology Validation Team Lead in Ocean County, New Jersey
Validation Team Lead
Engineering
Ocean County, NJ, US
- Added - 18/11/2024
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Our Client, a leading contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies, is seeking a Validation Engineer to join their growing team.
Position Overview
This role manages validation activities for equipment, critical utilities (e.g., WFI, compressed gases, clean steam), and facilities, supporting drug development and manufacturing. Responsibilities include creating and approving qualification protocols, ensuring compliance with regulatory standards, managing timelines.
Duties
Lead validation for equipment, utilities, and facilities.
Analyze data and ensure processes meet regulatory standards (FDA, ISO, EMA).
Schedule activities, manage resources, and meet project deadlines.
Collaborate with clients on deliverables and timelines.
Support investigations and technical troubleshooting.
Requirements
Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred).
5+ years of validation experience in an aseptic pharmaceutical/biotech environment.
Knowledge of FDA, GMP, ISO, EU, and ICH guidelines
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.