Hybrid Process Engineer III, Upstream – MSAT

Posted 3 weeks ago

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About the role

  • Promotes a culture of safety
  • Represents site MSAT on internal and external project teams as technical subject matter expert (SME)
  • Interfaces with global MSAT, Manufacturing Operations and Quality functions
  • Authors, reviews and approves GMP process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
  • Leads complicated and multi-disciplinary change controls and will function as a lead for the project team
  • Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions
  • Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation
  • Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
  • Lead quality and technical risk assessment activities
  • Support and/or lead technology transfer or new production introduction activities
  • Provide training and technical knowledge sharing to manufacturing
  • Partner with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners
  • Support and on-call rotating to support 24/7 operations
  • Confident to act as a subject matter expert for regulatory and client inspection audits
  • Apply Operational Excellence principles to lead continuous improvement ideas for manufacturing and technology transfer related activities

Requirements

  • Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience
  • Minimum of 2+ years of supporting upstream cell culture activities for biopharmaceutical products
  • Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs
  • Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology
  • Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology
  • Solid understanding of GMP concepts and quality systems necessary to support manufacturing and new production introduction activities
  • Working knowledge of manufacturing process equipment and automation systems
  • Experienced deviation investigator and knowledgeable of root cause analysis tools (RCA)
  • Possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
  • Ability to organize, analyze/interpret, and effectively communicate process data
  • Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders
  • Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.

Benefits

  • Discretionary annual bonus
  • Comprehensive benefits to include Medical, Dental and Vision
  • Short-term and long-term disability
  • Company paid basic life insurance
  • 401k company match
  • Flexible work
  • Generous paid time off and paid holiday
  • Wellness and transportation benefits

Job title

Process Engineer III, Upstream – MSAT

Job type

Experience level

Mid levelSenior

Salary

$92,400 - $126,500 per year

Degree requirement

Bachelor's Degree

Location requirements

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