Senior Engineer I, Validation
Bristol Myers Squibb
August 06, 2026
Remote friendly (Bothell, WA)
United States
Operations
Responsibilities:
- Ensure compliance with GMP asset management and validation requirements/industry standards in a regulated GMP manufacturing facility.
- Establish validation protocols, risk assessments, and qualification plans.
- Serve as Validation SME for multi-functional teams; advise on validation matters; present/defend validation programs/strategies before Health Authority inspectors and auditors.
- Execute qualification projects driven by change controls, capital projects, and supplemental validation deliverables.
- Collaborate cross-functionally (Facilities & Engineering, IT, Manufacturing, QC, Supply Chain, QA, Quality Engineering Validation) to prioritize, meet schedules, maximize productivity, reduce costs/COGM, and improve efficiencies.
- With minimal supervision, execute validation tasks and occasionally lead validation projects; support broader site initiatives.
- Review, prioritize, and respond to customer equipment qualification/support requests.
- Foster a culture of compliance, quality, and continuous improvement.
- Stay current with GMP regulations, FDA guidance, and international standards.
- Interface with regulatory agencies during inspections/audits as validation SME.
- Collaborate on validation-related findings; implement corrective actions.
- Oversee qualification/validation of lab instruments/equipment/systems (e.g., analytical instruments, autoclaves, environmental monitoring).
- Apply risk-based validation to optimize cycles while maintaining quality.
- Identify process optimization/efficiency improvements.
- Develop and deliver validation training programs.
Qualifications:
- Bachelor’s degree in life sciences/engineering/STEM (or equivalent experience).
- 5+ years CQV (commissioning/qualification/validation) in technical, regulated industries.
- Knowledge of cGMP, GDP, GXP, GAMP5, including 21 CFR Part 11, CSV, EU GMP Annex 15, and data integrity requirements.
- Experience with equipment/utility/facility qualifications and CQV practices.
- Investigations, deviations, and CAPA experience in regulated pharma is beneficial.
- Validation lifecycle documentation expertise (URS through IQ/OQ/PQ/SR; CSV through system retirement).
- Strong project/program management, communication, and technical writing.
- Experience with electronic document management systems is desired.
- Professional/technical competency to represent the department.
- Pharma/Biopharma experience required (cell therapy a plus).
- Detail oriented; strong GMP/Validation/Engineering experience.
- Ability to use regulatory knowledge to drive innovation/improvement.
Compensation (Bothell, WA, US): $107,000–$129,656; additional incentive cash/stock may be available based on eligibility.
Benefits (explicitly listed): Health coverage; wellbeing support; financial well-being/protection (401(k), disability, life/accident, supplemental health, etc.).
Work-life (explicitly listed): Paid time off options including flexible time off or 160 hours annual vacation depending on location/role type.
Application instructions:
- If the posting doesn’t perfectly match your resume, apply anyway.
- Ensure compliance with GMP asset management and validation requirements/industry standards in a regulated GMP manufacturing facility.
- Establish validation protocols, risk assessments, and qualification plans.
- Serve as Validation SME for multi-functional teams; advise on validation matters; present/defend validation programs/strategies before Health Authority inspectors and auditors.
- Execute qualification projects driven by change controls, capital projects, and supplemental validation deliverables.
- Collaborate cross-functionally (Facilities & Engineering, IT, Manufacturing, QC, Supply Chain, QA, Quality Engineering Validation) to prioritize, meet schedules, maximize productivity, reduce costs/COGM, and improve efficiencies.
- With minimal supervision, execute validation tasks and occasionally lead validation projects; support broader site initiatives.
- Review, prioritize, and respond to customer equipment qualification/support requests.
- Foster a culture of compliance, quality, and continuous improvement.
- Stay current with GMP regulations, FDA guidance, and international standards.
- Interface with regulatory agencies during inspections/audits as validation SME.
- Collaborate on validation-related findings; implement corrective actions.
- Oversee qualification/validation of lab instruments/equipment/systems (e.g., analytical instruments, autoclaves, environmental monitoring).
- Apply risk-based validation to optimize cycles while maintaining quality.
- Identify process optimization/efficiency improvements.
- Develop and deliver validation training programs.
Qualifications:
- Bachelor’s degree in life sciences/engineering/STEM (or equivalent experience).
- 5+ years CQV (commissioning/qualification/validation) in technical, regulated industries.
- Knowledge of cGMP, GDP, GXP, GAMP5, including 21 CFR Part 11, CSV, EU GMP Annex 15, and data integrity requirements.
- Experience with equipment/utility/facility qualifications and CQV practices.
- Investigations, deviations, and CAPA experience in regulated pharma is beneficial.
- Validation lifecycle documentation expertise (URS through IQ/OQ/PQ/SR; CSV through system retirement).
- Strong project/program management, communication, and technical writing.
- Experience with electronic document management systems is desired.
- Professional/technical competency to represent the department.
- Pharma/Biopharma experience required (cell therapy a plus).
- Detail oriented; strong GMP/Validation/Engineering experience.
- Ability to use regulatory knowledge to drive innovation/improvement.
Compensation (Bothell, WA, US): $107,000–$129,656; additional incentive cash/stock may be available based on eligibility.
Benefits (explicitly listed): Health coverage; wellbeing support; financial well-being/protection (401(k), disability, life/accident, supplemental health, etc.).
Work-life (explicitly listed): Paid time off options including flexible time off or 160 hours annual vacation depending on location/role type.
Application instructions:
- If the posting doesn’t perfectly match your resume, apply anyway.