Senior Validation Engineer
Job Summary
Leading validation activities in a GMP-regulated environment, the full-time Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation while providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations.
Key Responsibilities
- Lead the generation and execution of validation lifecycle documentation for equipment, utilities, and computerized systems
- Provide QA/Validation oversight for MES and eBR implementation, qualification, and lifecycle activities
- Review and approve validation documentation, ensuring compliance with regulatory requirements and internal quality standards
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field
- 7-11 years of experience in the biotechnology, pharmaceutical, or medical device industry
- Strong knowledge of FDA cGMP requirements and risk-based validation methodologies
- Advanced expertise in equipment qualification, process validation, and computerized systems validation
- Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, or similar systems is preferred
Complete Job Description
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