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Senior Process Engineer

2 months ago

Holly Springs, United States FUJIFILM Corporation Full time
Position Overview

This role is under the supervision of the Director of Process Engineering, focusing on the Process Equipment team. The selected candidate will play a crucial role in supporting a significant expansion project. The initial responsibilities will include overseeing the engineering aspects of washers and autoclaves.

As the facility transitions into operational phases, this position is expected to evolve into a dedicated Process Engineering role, concentrating on washers, autoclaves, and CIP. Below are detailed responsibilities associated with this position.

Key Responsibilities

Primary Duties


• Act as the liaison to the Engineering, Procurement, and Construction Management (EPC) provider.
• Ensure timely delivery and maintain quality standards from suppliers and EPCM providers for moderately complex equipment packages.
• Formulate and synchronize plans for moderate complexity projects and provide necessary mitigations.
• Evaluate piping and instrumentation diagrams (P&IDs) along with other process design documentation.
• Guide detailed design efforts in collaboration with the EPCM provider.
• Draft User Requirement Specifications (URSs).
• Assist in Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and startup operations.
• Serve as on-call support for process equipment issues.
• Review, annotate, and authorize P&IDs and other technical documents as the designated technical authority.
• Conduct system impact assessments and quality risk evaluations for process equipment.
• Facilitate technology transfer (TT) activities related to process equipment.
• Aid in the execution of Good Manufacturing Practices (GMP) runs.
• Provide technical assistance for root cause analysis (RCA) and process deviation inquiries.
• Lead or support deviations, change controls, and corrective and preventive action (CAPA) resolutions.
• Make informed decisions regarding technical risk assessments for new manufacturing equipment.
• Offer on-floor manufacturing support for equipment-related challenges.
• Deliver training and consultation on process equipment topics within assigned areas.
• Engage in identifying continuous improvement initiatives within unit operations, collaborating with Manufacturing as necessary to enhance manufacturability, reliability, yield, and cost efficiency.
• Support supplier technical evaluations, risk assessments, and equipment qualification processes.
• Conduct training sessions and present information to team members or other stakeholders.
• Participate in cross-training on unit operations to assist the team in meeting objectives.
• Collaborate with various departments, including Quality, Manufacturing, Process Science, Maintenance, and Automation.
• Undertake 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 engineering experience; or
• Master's degree in Chemical or Biotechnology Engineering with at least 3 years of relevant engineering experience.
• Experience in the Life Sciences or other regulated industries.
• Familiarity with engineering drawings and quality systems (e.g., deviation management, change control, CAPA, document management systems).

Preferred Qualifications


• Previous experience in a cGMP environment or another highly regulated sector.
• Experience in at least one unit operation within a pharmaceutical or Life Sciences 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.

PHYSICAL REQUIREMENTS
Physical Demands:
• Ability to work in environments that may require respiratory protection.
• May need to work in mechanical/production areas requiring hearing protection.
• Capability to operate a motor vehicle or powered industrial truck.
• Ability to discern audible cues and perform tasks requiring 20/20 corrected vision, including color distinction.

Working Environment:
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Capacity to stand or sit for extended periods.
• Ability to conduct repetitive motions involving wrists, hands, and fingers.
• Capability to operate machinery and/or power tools.
• Ability to lift and move objects as required.