Validation Engineer
Bristol Myers Squibb
2 hours ago
On-site
Bothell, WA
Operations
The Validation Engineer will play a critical role in ensuring compliance with regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility.
Key Responsibilities
- Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
- Serve as a validation Subject Matter Expert (SME) to multi-function teams; advise operations and present/defend validation programs and strategies before Health Authority inspectors and auditors.
- Execute qualification work driven by change controls, capital projects, and supplemental validation deliverables per approved validation plans.
- Collaborate cross-functionally (Facilities & Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance, Quality Engineering Validation) to manage workload, meet schedules, maximize productivity, reduce costs/COGM, and improve efficiencies.
- Execute validation projects/tasks with minimal supervision; occasionally lead validation projects.
- Review, prioritize, and respond to customer equipment qualification and support requests.
- Proactively support team members and demonstrate BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability).
- Foster a culture of compliance, quality, and continuous improvement within the validation team.
- Stay current on GMP regulations, FDA guidelines, and international standards.
- Interface with regulatory agencies during inspections/audits as the validation SME.
- Address validation findings with cross-functional teams and implement corrective actions as needed.
- Oversee qualification and validation of lab instruments/equipment/systems (e.g., analytical instruments, autoclaves, environmental monitoring systems).
- Implement risk-based validation to optimize processes and reduce validation cycle times while maintaining quality.
- Identify validation process optimization and efficiency improvements.
- Develop and deliver training programs for validation team members.
Qualifications & Experience
- Bachelor’s degree in life sciences, engineering, STEM, or equivalent.
- 2+ years of commissioning, qualification, and validation (CQV) experience in technical and regulated industries.
- Knowledge of cGMP, GDP, GXP, GAMP5; including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity requirements.
- Experience with equipment/utility/facility qualifications and general CQV practices.
- Experience with investigations, deviations, and CAPA management (beneficial).
- In-depth understanding of validation lifecycle deliverables from URS through IQ/OQ/PQ and SR; and computer system validation (CSV) through system retirement.
- Strong project/program management, communication, and technical writing skills.
- Knowledge/experience with electronic document management systems for quality and validation records (desired).
- Ability to represent the department professionally to customers, regulatory agencies, and management.
- Pharma/Biopharma experience required; cell therapy experience is a plus.
- Detail oriented with strong GMP, validation, and engineering experience.
- Experience using regulatory knowledge to drive innovation and improvement in validation/engineering.
Compensation Overview
- Bothell, WA, US: $83,220–$100,847 (full-time).
Benefits (explicitly listed)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, EAP.
- Financial Well-being/Protection: 401(k), short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off: flexible time off (unlimited with manager approval) for US exempt employees; 11 paid national holidays; and location-specific paid vacation/holidays for Phoenix, AZ / Puerto Rico / Rayzebio employees.
- Additional time off based on eligibility may include paid sick time, volunteer days, summer hours flexibility, leaves of absence, and annual Global Shutdown.
Application Instructions
- Apply for the role; if a role doesn’t perfectly match your resume, they encourage you to apply anyway.
Key Responsibilities
- Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
- Serve as a validation Subject Matter Expert (SME) to multi-function teams; advise operations and present/defend validation programs and strategies before Health Authority inspectors and auditors.
- Execute qualification work driven by change controls, capital projects, and supplemental validation deliverables per approved validation plans.
- Collaborate cross-functionally (Facilities & Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance, Quality Engineering Validation) to manage workload, meet schedules, maximize productivity, reduce costs/COGM, and improve efficiencies.
- Execute validation projects/tasks with minimal supervision; occasionally lead validation projects.
- Review, prioritize, and respond to customer equipment qualification and support requests.
- Proactively support team members and demonstrate BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability).
- Foster a culture of compliance, quality, and continuous improvement within the validation team.
- Stay current on GMP regulations, FDA guidelines, and international standards.
- Interface with regulatory agencies during inspections/audits as the validation SME.
- Address validation findings with cross-functional teams and implement corrective actions as needed.
- Oversee qualification and validation of lab instruments/equipment/systems (e.g., analytical instruments, autoclaves, environmental monitoring systems).
- Implement risk-based validation to optimize processes and reduce validation cycle times while maintaining quality.
- Identify validation process optimization and efficiency improvements.
- Develop and deliver training programs for validation team members.
Qualifications & Experience
- Bachelor’s degree in life sciences, engineering, STEM, or equivalent.
- 2+ years of commissioning, qualification, and validation (CQV) experience in technical and regulated industries.
- Knowledge of cGMP, GDP, GXP, GAMP5; including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity requirements.
- Experience with equipment/utility/facility qualifications and general CQV practices.
- Experience with investigations, deviations, and CAPA management (beneficial).
- In-depth understanding of validation lifecycle deliverables from URS through IQ/OQ/PQ and SR; and computer system validation (CSV) through system retirement.
- Strong project/program management, communication, and technical writing skills.
- Knowledge/experience with electronic document management systems for quality and validation records (desired).
- Ability to represent the department professionally to customers, regulatory agencies, and management.
- Pharma/Biopharma experience required; cell therapy experience is a plus.
- Detail oriented with strong GMP, validation, and engineering experience.
- Experience using regulatory knowledge to drive innovation and improvement in validation/engineering.
Compensation Overview
- Bothell, WA, US: $83,220–$100,847 (full-time).
Benefits (explicitly listed)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, EAP.
- Financial Well-being/Protection: 401(k), short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off: flexible time off (unlimited with manager approval) for US exempt employees; 11 paid national holidays; and location-specific paid vacation/holidays for Phoenix, AZ / Puerto Rico / Rayzebio employees.
- Additional time off based on eligibility may include paid sick time, volunteer days, summer hours flexibility, leaves of absence, and annual Global Shutdown.
Application Instructions
- Apply for the role; if a role doesn’t perfectly match your resume, they encourage you to apply anyway.