Process Engineer 3 - Washers/Autoclaves

Merck & Co.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM seeks a Process Engineer 3 to guide capital projects, technology transfer, and manufacturing operations, ensuring safety and regulatory compliance. You will optimize plant efficiency, support startup activities, and lead or assist with deviations and CAPA closures.

The role requires collaboration across Quality, Manufacturing, Process Science, and Automation, with strong communication and project management skills to drive continuous improvement.

Qualifications

• Bachelor's degree in Chemical or Biotechnology Engineering with 5 years relevant experience.
• Master's degree with 3 years relevant experience in Life Science or regulated industry.
• Experience with engineering drawings and Quality Systems such as deviation management, change control, and CAPA.

Responsibilities

• Acts as point of contact to the EPC provider and coordinates with engineering teams.
• Reviews P&IDs and other process design documents; provides direction to detailed design.
• Writes User Requirement Specifications (URSs) and supports FAT, CQV, and startup activities.
• Leads or supports GMP runs and assists with CAPA closures and deviation investigations.
• Provides on-floor manufacturing support and participates in continuous improvement projects.
• Collaborates with Quality, Manufacturing, Process Science, Maintenance, and Automation.

Skills

Relationship building

Effective communication

Advanced problem solving

Project management

Technical presentation

Feedback to leaders

Cross-functional collaboration

Education

Bachelor's degree in Chemical or Biotechnology Engineering

Master's in Chemical or Biotechnology Engineering

Tools

Engineering drawings

Quality Systems

Job description

Position Overview

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.

Job Description

What You'll Do

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider
• Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages
• Develops and aligns moderate complexity plans and provides mitigations, as needed
• Reviews piping and instrumentation diagram (P&IDs) and other process design documents
• Provides direction to detailed design activities in partnership with the EPCM provider
• Writes User Requirement Specifications (URSs)
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
• Serves as on-call support for process equipment
• Reviews, redlines, and approves P&IDs and other technical documents as the technical authority
• Leads system impact assessments and quality risk assessments for process equipment
• Performs technology transfer (TT) activities related to process equipment
• Supports execution of Good Manufacturing Practices (GMP) runs
• Provides technical support for root cause analysis (RCA) and process deviation investigations
• Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
• Makes decisions regarding technical risk assessments for new manufacturing equipment
• Provides on-floor manufacturing support for equipment issues
• Provides process equipment training and consultation on topics within assigned area(s)
• Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification
• Conducts training and presents information to team or other stakeholders
• Cross-trains on unit operations to assist team with achieving deliverables
• Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
• Other duties, as assigned

Knowledge and Skills

• Ability to develop effective working relationships internally and externally
• Effective communication, both written and oral
• Advanced problem-solving skills
• Proficient Project Management skills
• Ability to effectively present complex information to others
• Ability to provide feedback to others, including leaders
• Ability to adapt communication style to differing audiences and advise on difficult matters

Basic Requirements

• Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or
• Master's in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience
• Experience in Life Science or other regulated industry
• Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system)

Preferred Requirements

• Prior experience working in a cGMP environment or other highly regulated industry
• Experience working in at least one unit operation in a pharmaceutical or Life Science environment
• Experience with mammalian cell culture processes

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection. No X Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
• Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
• Ability to stand for prolonged periods of time. No X Yes 30 minutes
• Ability to sit for prolonged periods of time. No X Yes 120 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
• Ability to operate machinery and/or power tools. X No Yes
• Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.