Validation Engineer II
About The Position
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Requirements
- Bachelor's degree in Chemical, Biomedical, Mechanical Engineering, or a related scientific discipline.
- 2–6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
- Hands-on experience with IQ, OQ, and PQ.
- Hands-on experience in temperature mapping for Controlled Temperature Units.
- Strong knowledge of cGMP requirements.
- Knowledge of ICH guidelines.
- Knowledge of FDA 21 CFR Parts 210, 211, and 820.
- Familiarity with FDA and cGMP standards.
- Experience with CQV deliverables.
- Experience in validation data analysis, deviation handling, and CAPA.
- Experience with change controls for validated systems.
- Strong documentation, communication, and cross-functional coordination skills.
Responsibilities
- Develop and execute validation protocols and reports for equipment, utilities, and facilities.
- Develop and execute CQV deliverables for temperature mapping of Controlled Temperature Units.
- Coordinate validation activities with Manufacturing, Quality Assurance, Engineering, and R&D.
- Analyze validation data and identify deviations.
- Recommend corrective and preventive actions (CAPAs).
- Prepare and present validation summaries and reports to internal and external auditors.
- Participate in the review and approval of change controls related to validated systems.
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What This Job Offers
Career Level
Mid Level
