Senior Engineer I Validation
Overview
Lead validation efforts at a BMS facility to ensure GMP compliance and operational excellence. Drive validation projects and mentor team members to achieve high-quality outcomes. Shape the future of patient care through innovative solutions.
What You'll Do5
- 1Design and execute validation protocols for GMP asset management and validation processes
- 2Act as SME supporting cross-functional teams in validation matters
- 3Oversee qualification and validation of laboratory equipment and systems
- 4Implement risk-based validation approaches to optimize processes and reduce cycle times
- 5Develop training programs to enhance validation team capabilities
Requirements5
- 1Bachelor’s degree in life sciences engineering or STEM with 5+ years of CQV experience
- 2Robust knowledge of cGMP GDP GXP GAMP5 regulations and 21CFR Part 11 requirements
- 3Experience with equipment/utility/facility qualifications and commissioning practices
- 4Proven track record managing investigations deviations and CAPA in pharma environments
- 5Pharma/biopharma background with preference for cell therapy industry experience
Salary Insight
$107 - $130k per year
Location
Required Skills
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