Validation Associate Engineer
Bristol Myers Squibb
July 02, 2026
On-site
Bothell, WA
Operations
Validation Associate Engineer
Key Responsibilities
- Support the Periodic Review and Periodic Requalification program (Bothell, WA and Seattle, WA), including temperature mapping studies and development of Periodic Reviews.
- With oversight, generate validation protocols, specifications, reports, and qualification plans for GMP operations.
- Perform Validation Impact Assessments for work orders of qualified equipment, utilities, and facilities.
- Support qualification work from change controls, capital projects, and supplemental validation deliverables per approved plans (under a senior Validation Engineer).
- Collaborate with cross-functional teams (Facilities/Engineering, IT, Manufacturing, QC, Supply Chain, QA, and Validation).
Qualifications & Experience
- Bachelor’s degree in life sciences/engineering/STEM (or equivalent).
- 2 years’ GMP experience (pharmaceutical manufacturing operations/support preferred).
- Recommended: commissioning/qualification/validation (CQV) in regulated industries.
- Awareness of cGMP/GDP/GXP/GAMP5, including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity.
- Beneficial: equipment/utility/facility qualification CQV practices; investigations/deviations/CAPA.
- Beneficial: validation lifecycle deliverables (URS through IQ/OQ/PQ/SR) and computer system validation (CSV) through retirement.
- Required: strong project/program management, communication, and technical writing.
- Desired: electronic document management systems.
Benefits / Compensation (explicit)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, and financial protection (401(k), disability, life insurance, etc.).
- Bothell, WA: $83,220–$100,847.
Application Instruction
- If the role doesn’t perfectly match your resume, apply anyway.
Key Responsibilities
- Support the Periodic Review and Periodic Requalification program (Bothell, WA and Seattle, WA), including temperature mapping studies and development of Periodic Reviews.
- With oversight, generate validation protocols, specifications, reports, and qualification plans for GMP operations.
- Perform Validation Impact Assessments for work orders of qualified equipment, utilities, and facilities.
- Support qualification work from change controls, capital projects, and supplemental validation deliverables per approved plans (under a senior Validation Engineer).
- Collaborate with cross-functional teams (Facilities/Engineering, IT, Manufacturing, QC, Supply Chain, QA, and Validation).
Qualifications & Experience
- Bachelor’s degree in life sciences/engineering/STEM (or equivalent).
- 2 years’ GMP experience (pharmaceutical manufacturing operations/support preferred).
- Recommended: commissioning/qualification/validation (CQV) in regulated industries.
- Awareness of cGMP/GDP/GXP/GAMP5, including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity.
- Beneficial: equipment/utility/facility qualification CQV practices; investigations/deviations/CAPA.
- Beneficial: validation lifecycle deliverables (URS through IQ/OQ/PQ/SR) and computer system validation (CSV) through retirement.
- Required: strong project/program management, communication, and technical writing.
- Desired: electronic document management systems.
Benefits / Compensation (explicit)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, and financial protection (401(k), disability, life insurance, etc.).
- Bothell, WA: $83,220–$100,847.
Application Instruction
- If the role doesn’t perfectly match your resume, apply anyway.