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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 Equipment team, reporting directly to the Director of Process Engineering. The selected candidate will play a crucial role in supporting a significant expansion project. The initial focus will be on overseeing the engineering responsibilities for specific equipment.

As operations transition to commercial phases, this position is expected to evolve into a broader Process Engineering role, concentrating on key equipment such as washers, autoclaves, and CIP. Below are the primary responsibilities associated with this role.

Key Responsibilities:

  • Act as the main liaison with the Engineering, Procurement, and Construction Management (EPC) team.
  • Ensure timely delivery and maintain quality standards from equipment suppliers.
  • Develop and coordinate plans for moderate complexity projects, implementing necessary mitigations.
  • Review and analyze piping and instrumentation diagrams (P&IDs) and related design documents.
  • Guide detailed design processes in collaboration with the EPC team.
  • Create User Requirement Specifications (URSs).
  • Assist in Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and startup procedures.
  • Provide on-call support for process equipment as needed.
  • Review and approve technical documents, serving as the technical authority.
  • Lead assessments related to system impacts and quality risks for process equipment.
  • Facilitate technology transfer activities associated with process equipment.
  • Support the execution of Good Manufacturing Practices (GMP) operations.
  • Offer technical assistance for root cause analysis and process deviation investigations.
  • Oversee deviations, change controls, and corrective and preventive action (CAPA) resolutions.
  • Make informed decisions regarding technical risks associated with new manufacturing equipment.
  • Provide hands-on support for manufacturing equipment issues.
  • Deliver training and consultation on process equipment topics.
  • Identify opportunities for continuous improvement in manufacturing processes.
  • Assist in supplier evaluations and risk assessments.
  • Conduct training sessions and present information to stakeholders.
  • Collaborate with various departments, including Quality, Manufacturing, Process Science, Maintenance, and Automation.
  • Perform additional 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 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 a similarly regulated industry.
  • Familiarity with engineering drawings and quality management systems.

Preferred Qualifications:

  • Experience in a cGMP environment or other highly regulated sectors.
  • Hands-on experience in at least one unit operation within a pharmaceutical or Life Science context.
  • 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.