Senior Specialist, Validation Engineer II
Bristol Myers Squibb
Bristol Myers Squibb seeks a Senior Specialist, Validation Engineer II to support manufacturing and laboratory equipment qualification at a multi-use pharmaceutical site. The role involves developing validation deliverables, maintaining qualified systems, executing projects, and providing technical support to internal and external stakeholders.
Responsibilities
- Develop and execute validation deliverables including plans, specifications, and summary reports
- Support equipment qualification activities and develop qualification protocols with associated documentation
- Execute validation lifecycle maintenance including document hierarchy establishment and change control tracking
- Respond to equipment qualification requests and provide technical guidance to site customers
- Contribute to regulatory audit readiness and serve as subject matter expert in internal and regulatory inspections
Requirements
- Bachelor of Science degree in Chemical Engineering or equivalent
- Direct experience with equipment commissioning, facility qualification, and critical utilities validation
- Working knowledge of cGMP, FDA/EMA regulatory requirements, and ICH Q7/Q8/Q9 guidelines
- Proficiency in project management, technical writing, and communication skills
- Knowledge of distributed control systems, GAMP automation validation, and quality systems design
- Strong problem-solving abilities and ability to manage multiple priorities independently
Vacancy posted 5 days ago
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