Senior Specialist, Validation Engineer - CSV
$92.54k - $112.14kBristol Myers Squibb
Bristol Myers Squibb seeks a Senior Specialist Validation Engineer to qualify process control and manufacturing execution systems supporting clinical and commercial biologics manufacturing. The role involves managing validation protocols, test execution, and compliance documentation for automated GMP manufacturing systems at a Devens, MA facility.
Responsibilities
- Execute validation efforts for GMP manufacturing systems including process automation and manufacturing execution systems
- Generate, execute, and manage test protocols for configuration changes to DeltaV and Syncade systems
- Assess validation work arising from change controls, capital projects, and revalidation programs
- Provide validation support to multi-functional teams and advise operations on compliance matters
- Ensure alignment with BMS directives and industry validation guidelines
Requirements
- Minimum 2 years developing or testing process automation system software, preferably DeltaV batch
- Bachelor's degree in chemical engineering, related discipline, or equivalent experience
- Validation experience in biopharmaceutical industry or equivalent role
- Knowledge of DCS and PLC systems, preferably in pharmaceutical context
- Understanding of cGMPs, SOPs, and regulatory guidelines (FDA, EU)
- Project management, technical writing, and communication skills
- Familiarity with large-scale distributed control systems desired
Compensation: $92,540 - $112,136
Vacancy posted 5 days ago
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