Senior Engineer, It Computer System Validation (csv)
Bristol Myers Squibb UK
Devens, MA, United States
Base: $99,480 - $120,551; bonus/equity: not specif...
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Computer system validation (csv) expertise
Gxp supporting systems knowledge
Regulatory agency defense experience
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Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation at their Devens, MA facility. The role focuses on managing computerized system validation activities, ensuring compliance with regulatory requirements, and collaborating with various teams to uphold quality standards.
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Job Summary
The Senior Engineer, IT Computer System Validation, Cell Therapy Devens role will provide support to the Digital Plant team at the Devens Cell Therapy Facility through managing computerized system validation (CSV) activities and supporting deviations and change controls.
This position requires acting as a CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects, advising operations on CSV matters and defending work before regulatory agencies.
The role involves driving and owning the validation lifecycle documentation for newly implemented computerized systems and participating in regulatory audits as a Digital Plant secondary representative.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation at their Devens, MA facility. The role focuses on managing computerized system validation activities, ensuring compliance with regulatory requirements, and collaborating with various teams to uphold quality standards.
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Salary
Base: $99,480 - $120,551; Bonus/Equity: Not specified; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
Computer System Validation (CSV) expertise
GxP supporting systems knowledge
Regulatory agency defense experience
Validation lifecycle documentation ownership
IT quality support for Digital Plant
Nice-to-have
Collaboration with diverse teams
High quality assurance mindset
Project management of automation systems
Proactive risk assessment and management
Key Requirements
Minimum six (6) years of relevant experience
Four (4) years focused on QA, validation, or compliance for computerized systems
Knowledge of CSV principles, GAMP 5, FDA 21 CFR Part 11, and data integrity
Proficiency in project management, oral communication, and technical writing