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Senior Process Engineer

2 months ago

Holly Springs, United States FUJIFILM Corporation Full time

Position Overview:
This role is integral to the Process Engineering team, reporting directly to the Process Engineering Manager within the Downstream sector. The successful candidate will be pivotal in supporting the Process Equipment team on significant projects.

Key Responsibilities:

  • Act as the primary liaison with the Engineering, Procurement, and Construction Management (EPCM) provider.
  • Ensure timely delivery and uphold quality standards from suppliers for equipment packages of moderate complexity.
  • Formulate and align plans while providing necessary mitigations.
  • Conduct thorough reviews of piping and instrumentation diagrams (P&IDs) and other essential process design documents.
  • Guide detailed design efforts in collaboration with the EPCM provider.
  • Draft User Requirement Specifications (URSs).
  • Facilitate Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and startup activities.
  • Provide on-call support for process equipment issues.
  • Review, annotate, and authorize P&IDs and other technical documents as the technical authority.
  • Lead system impact assessments and quality risk evaluations for process equipment.
  • Conduct technology transfer activities related to process equipment.
  • Support the execution of Good Manufacturing Practices (GMP) runs.
  • Offer technical assistance for root cause analysis (RCA) and process deviation investigations.
  • Lead or assist in managing deviations, change controls, and corrective and preventive action (CAPA) closures.
  • Make informed decisions regarding technical risk assessments for new manufacturing equipment.
  • Provide on-floor manufacturing support for equipment-related challenges.
  • Deliver training and consultation on process equipment topics within assigned areas.
  • Identify and participate in continuous improvement initiatives within unit operations to enhance manufacturability, reliability, yield, and cost.
  • Assist in supplier technical evaluations, risk assessments, and equipment qualification.
  • Conduct training sessions and present information to teams or stakeholders.
  • Cross-train on unit operations to aid the team in achieving objectives.
  • Collaborate with various departments, including Quality, Manufacturing, Process Science, Maintenance, and Automation.
  • Perform other duties as assigned.

Minimum Qualifications:

  • Bachelor's degree in Chemical or Biotechnology Engineering, or a related field with a minimum of 5 years of relevant engineering experience; or a Master's degree in Chemical or Biotechnology Engineering with at least 3 years of relevant experience.
  • Experience in the Life Sciences or other regulated industries.
  • Familiarity with engineering drawings and quality systems, including deviation management, change control, CAPA, and document management systems.

Preferred Qualifications:

  • Previous experience in a cGMP environment or other highly regulated industries.
  • Experience in at least one unit operation within a pharmaceutical or Life Sciences setting.
  • Knowledge of mammalian cell culture processes.

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.