Senior Process Engineering Specialist

2 weeks ago


Holly Springs, United States FUJIFILM Corporation Full time

Position Overview:

As a pivotal member of the Process Engineering team, you will report directly to the Director of Process Engineering. This role is essential in supporting the Process Equipment team, focusing on high-stakes projects within the biopharmaceutical sector.

Key Responsibilities:

  • Act as the primary liaison with the Engineering, Procurement, and Construction Management (EPCM) provider for intricate equipment packages.
  • Ensure timely delivery and adherence to quality standards from suppliers.
  • Develop and synchronize plans for complex projects, implementing mitigations as necessary.
  • Review and analyze piping and instrumentation diagrams (P&IDs) alongside other critical process design documents.
  • Guide detailed design activities in collaboration with the EPCM provider.
  • Draft User Requirement Specifications (URSs) to align project objectives.
  • Support Factory Assessment Tests (FATs), Commissioning, Qualification and Validation (CQV), and start-up initiatives.
  • Provide on-call assistance for process equipment issues.
  • Review and approve technical documents, serving as the technical authority.
  • Lead system impact assessments and quality risk evaluations for process equipment.
  • Facilitate technology transfer activities related to process equipment.
  • Support the execution of Good Manufacturing Practices (GMP) operations.
  • Deliver technical assistance for root cause analysis (RCA) and process deviation investigations.
  • Oversee the closure of deviations and corrective actions.
  • Make informed decisions regarding technical risk assessments for new manufacturing equipment.
  • Offer on-floor support for manufacturing equipment challenges.
  • Conduct training sessions and provide consultation on specialized topics within your area of expertise.
  • Identify and implement continuous improvement initiatives to enhance manufacturability, reliability, yield, and cost-effectiveness.
  • Engage in supplier technical evaluations and risk assessments.
  • Collaborate with various departments, including Quality, Manufacturing, Process Science, Maintenance, and Automation.

Qualifications:

Basic Requirements:

  • Bachelor's degree in Chemical or Biotechnology Engineering, or a related field with a minimum of 8 years of relevant engineering experience; or a Master's degree with at least 6 years of experience.
  • Proven experience in the Life Sciences or other regulated industries.
  • Familiarity with engineering drawings and quality systems.

Preferred Qualifications:

  • Experience in a cGMP environment or similar highly regulated settings.
  • Background in large-scale mammalian cell culture processes.
  • Experience managing large-scale capital projects exceeding $500 million.

FUJIFILM Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.



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