MSAT Bioengineer – DSP

Global MSAT

About the Job

Position Summary:

As an MSAT Bioengineer – DSP, you are responsible for internal/external technology transfers and manufacturing support covering downstream purification processes (DSP) in BIB’s lab and biologics manufacturing facilities. As a DSP 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 downstream purification 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 chromatography, depth filtration, nanofiltration, tangential flow filtration, scale up, 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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