Senior Specialist, MSAT Cell Therapy Engineering Services, Aseptic Processing & Environmental Controls
Bristol Myers Squibb
6 months ago
On-site
Bothell, WA
Operations
Position Summary
- Senior Specialist, MSAT Cell Therapy Engineering Services, Aseptic Processing & Environmental Controls supports the production of personalized cell therapy products for clinical and commercial supply at the BMS Manufacturing Plant (Jump) in Bothell, WA.
- Supports compliance of aseptic processes and environmental control systems.
- Supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs within the Bothell Manufacturing Sciences and Technology (MSAT) department.
Responsibilities
- Support the AEC team in planning, development, execution, and authoring of reports on APS, AVS, CRC, EMPQ, and NRS activities.
- Coordinate with cross-functional teams: Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control, and Validation.
- Investigate and resolve deviations and non-conformances with oversight from Validation and Quality Assurance leadership.
- Support development of the requalification schedule for routine APS and CRC.
- Develop and manage electronic validation documentation (risk assessments, protocols, studies, reports) using ValGenesis validation lifecycle information management system and Infinity.
- Serve as a subject matter expert (SME) for aseptic and environmental control programs.
- Own impact assessments, quality actions, and support production-related investigations to maintain the validated state of the aseptic process.
- Ensure compliance with regulatory requirements and industry standards for aseptic and environmental control.
- Assist on one or more projects within the AEC area.
Qualifications
- Bachelor’s Degree in life sciences/engineering/STEM or equivalent.
- 3+ years relevant experience in biologics or cell therapy manufacturing/development with BS, or 2+ years with MS.
- Knowledge of cGMP, GDP, GXP, including 21 CFR Part 11 and EU GMP.
- Annex and multi-national regulations for aseptic processes and environmental control systems (preferred).
- Knowledge of microbiology, aseptic processing, and facility qualification (preferred).
- Excellent project/program management, communication, and technical writing skills.
Benefits (explicitly listed)
- Health Coverage: Medical, pharmacy, dental, vision.
- Wellbeing Support programs (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, 11 paid national holidays) for US exempt employees; 160 hours annual paid vacation (with manager approval), 11 national holidays, and 3 optional holidays for certain exempt/non-exempt/hourly employees.
- Senior Specialist, MSAT Cell Therapy Engineering Services, Aseptic Processing & Environmental Controls supports the production of personalized cell therapy products for clinical and commercial supply at the BMS Manufacturing Plant (Jump) in Bothell, WA.
- Supports compliance of aseptic processes and environmental control systems.
- Supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs within the Bothell Manufacturing Sciences and Technology (MSAT) department.
Responsibilities
- Support the AEC team in planning, development, execution, and authoring of reports on APS, AVS, CRC, EMPQ, and NRS activities.
- Coordinate with cross-functional teams: Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control, and Validation.
- Investigate and resolve deviations and non-conformances with oversight from Validation and Quality Assurance leadership.
- Support development of the requalification schedule for routine APS and CRC.
- Develop and manage electronic validation documentation (risk assessments, protocols, studies, reports) using ValGenesis validation lifecycle information management system and Infinity.
- Serve as a subject matter expert (SME) for aseptic and environmental control programs.
- Own impact assessments, quality actions, and support production-related investigations to maintain the validated state of the aseptic process.
- Ensure compliance with regulatory requirements and industry standards for aseptic and environmental control.
- Assist on one or more projects within the AEC area.
Qualifications
- Bachelor’s Degree in life sciences/engineering/STEM or equivalent.
- 3+ years relevant experience in biologics or cell therapy manufacturing/development with BS, or 2+ years with MS.
- Knowledge of cGMP, GDP, GXP, including 21 CFR Part 11 and EU GMP.
- Annex and multi-national regulations for aseptic processes and environmental control systems (preferred).
- Knowledge of microbiology, aseptic processing, and facility qualification (preferred).
- Excellent project/program management, communication, and technical writing skills.
Benefits (explicitly listed)
- Health Coverage: Medical, pharmacy, dental, vision.
- Wellbeing Support programs (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, 11 paid national holidays) for US exempt employees; 160 hours annual paid vacation (with manager approval), 11 national holidays, and 3 optional holidays for certain exempt/non-exempt/hourly employees.