Validation Associate Engineer
Position Overview We are seeking a Validation Associate Engineer to support GMP compliance and validation activities across BMS sites in Bothell and Seattle, WA.
Key Responsibilities Support the Periodic Review and Periodic Requalification program at BMS sites in Bothell, WA and Seattle, WA, including execution of requalification activities such as temperature mapping studies, and development of Periodic Reviews.
Generate validation protocols, specifications, reports, and qualification plans under oversight to support GMP operations.
Perform Validation Impact Assessments for on‑demand work orders of qualified equipment, utilities, and facilities.
Support projects requiring qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverables per approved validation plans under direction of a senior Validation Engineer.
Work collaboratively with peers within cross‑functional teams (Facilities and Engineering, IT, Manufacturing, QC, Supply Chain, QA, and Quality Engineering Validation) to support projects and qualification work.
Proactively support other Validation team members and help them to be successful.
Seek opportunities to learn and practice BMS values; demonstrate BMS values of integrity, innovation, passion, urgency, inclusion, and accountability.
Qualifications & Experience Bachelor’s Degree in life sciences, engineering, STEM or equivalent.
2 years of experience in a GMP setting, preferably pharmaceutical manufacturing operations or support.
Experience with commissioning, qualification, and validation (CQV) within technical and regulated industries.
Awareness of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements.
Experience with equipment/utility/facility qualifications and general commissioning, qualification and validation CQV practices.
Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry.
Experience with validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ and SR) and computer system validation (CSV) documents through system retirement.
Strong project and program management, communication, and technical writing skills.
Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents.
Compensation Overview Bothell, WA – US: $83,220 – $100,847. This is the starting compensation range for a full‑time employee. Additional incentive cash and stock opportunities may be available, subject to eligibility.
Benefits Benefits include health coverage (medical, pharmacy, dental, vision), wellbeing support programs, 401(k) plan, disability insurance, life insurance, paid time off, global shutdown, and other financial well‑being and protection benefits. Eligibility for specific benefits may vary by job and location.
Equal Employment Opportunity Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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