Senior Specialist, Msat Cell Therapy Engineering Services, Aseptic Processing & Environmental Controls

Bristol Myers Squibb

Bothell, WA, United States
Base: $95,130 - $115,278; bonus/equity: not specif...
On-site
Aseptic process simulation (aps)
Airflow visualization study (avs)
Environmental monitoring performance qualification (empq)
Bristol Myers Squibb is seeking a Senior Specialist in MSAT Cell Therapy Engineering Services, focusing on aseptic processing and environmental controls. The role involves supporting the production of personalized cell therapy products while ensuring compliance with regulatory standards and offering opportunities for professional growth

Job Summary

  • This role provides support to ensure the compliance of aseptic processes and environmental control systems for personalized cell therapy products.
  • Responsibilities include planning, development, execution, and authoring of reports on aseptic and environmental control activities, and investigating deviations.
  • The company offers a wide variety of competitive benefits, services, and programs to support employees' goals at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Specialist in MSAT Cell Therapy Engineering Services, focusing on aseptic processing and environmental controls. The role involves supporting the production of personalized cell therapy products while ensuring compliance with regulatory standards and offering opportunities for professional growth.

Salary

Base: $95,130 - $115,278; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Aseptic process simulation (APS)
  • Airflow visualization study (AVS)
  • Environmental monitoring performance qualification (EMPQ)
  • Cleanroom reclassification (CRC)
  • Non-routine simulation (NRS)
  • ValGenesis validation lifecycle management system

Nice-to-have

  • Cellular therapy systems expertise
  • Microbiology knowledge
  • Strong technical writing skills
  • Cross-functional team coordination

Key Requirements

  • Bachelor's Degree in life sciences/engineering/STEM or equivalent
  • 3+ years relevant experience with BS
  • 2+ years relevant experience with MS
  • Knowledge of cGMP, GDP, GXP
  • Knowledge of 21CFR part 11, EU GMP Annex

Work Rights

Not specified

Tailored Resume

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