MSAT Bioengineer – USP

Global MSAT

About the Job

Position Summary:

As an MSAT Bioengineer – USP , you are responsible for internal/external technology transfers and manufacturing support covering upstream cell culture/fermentation processes (USP) in BIB’s lab and biologics manufacturing facilities. As an USP Subject Matter Expert of global MSAT, you will provide advice and guidance on manufacturing technology issues, initiatives, and strategies for continuously improving manufacturing performance.

Responsibilities:

  • Perform technology transfer activities among client, internal R&D/process development team, and GMP Manufacturing site focusing on upstream cell culture/fermentation related processes.
  • Perform Risk Assessment & Mitigation during product technology transfer and manufacturing.
  • Support equipment IQ, OQ, PQ, deviation investigation, CAPA, and change control.
  • Draft and review Manufacturing Process Description, Process Flow Diagram, Bill of Materials, Sampling Plan, Risk Assessment & Mitigation Plan, Data Trending and Statistical Analysis, and Process Performance Qualification/Process Validation Protocols.
  • Review GMP or non-GMP documents including SOPs, batch records, production reports, and other related documents to fulfill CMC requirements.
  • Maintain all notebooks and documentation according to department standards.
  • Work well in a team environment and independently as required.
  • Ensure and promote safe environmental and laboratory practices.

Qualifications:

  • MS/BS degrees in Chemical Engineering, Biochemical Engineering, or related fields.
  • MS with 3+ years or BS with 5+ years of hands-on experience in bioprocess related working environment.
  • In depth understanding and hands-on experience on upstream cell culture/fermentation, primary recovery, scale up, aseptic techniques, and other related unit operations.
  • Familiar with process simulation software such as SuperPro or Aspen Plus.
  • Excellent troubleshooting and communication skills.
  • Demonstrating ability to solve practical problems.
  • Proven ability to work independently and on cross-functional teams
Please email your resume and why you believe you are a good fit for this position directly to career@bostonbib.com Thank you!

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