Process Engineer 1

Merck & Co.; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a Process Engineer 1 to support capital projects, technology transfer, and manufacturing operations. You will ensure compliance with safety, regulatory and engineering requirements while helping optimize plant efficiency and profitability.

The role emphasizes equipment support, design review, URS creation, and participation in GMP runs, CQV, FAT, and on-floor issue resolution.

Qualifications

• Minimum bachelor’s degree in a related engineering field.
• 0–1 year of engineering or related technical experience.
• Exposure to cGMP environments is preferred.

Responsibilities

• Provide engineering guidance to support capital projects and technology transfer.
• Review P&IDs and other process design documents with supervision.
• Write User Requirement Specifications (URSs).
• Support FAT, CQV, and start-up activities with supervision.
• Assist with deviations, CAPA closures, and root cause investigations.
• Collaborate with Quality, Manufacturing, Maintenance, Validation, and Safety.

Skills

GMP knowledge

Technical writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Biotechnology Engineering

Tools

P&IDs review

URS writing

Job description

Position Overview

The Process Engineer 1 will provide 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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You\'ll Do:

• Supports on time delivery and ensures quality from Fujifilm and Engineering, Procurement, Construction Management (EPCM) provider
• Supports piping and instrumentation diagram (P&IDs) and other process design document review
• Provides input to detailed design activities in partnership with EPCM provider
• Writes User Requirement Specifications (URSs)
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification, and Validation (CQV), and start-up activities with supervision
• Serves as on-call support for process equipment
• Reviews, redlines, and approves P&IDs and other technical documents with supervision
• Contributes to system impact assessments and quality risk assessments for process equipment
• Supports 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
• Assists with deviations, change controls, corrective and preventive action (CAPA) closures
• Supports technical risk assessments for new manufacturing equipment
• Provides on-floor manufacturing support for equipment issues
• Cross-trains on unit operations to assist team with meeting deliverables
• Collaborates with other departments, such as Quality, Manufacturing, Maintenance, Validation, and Safety.
• Other duties, as assigned

Minimum Requirements:

• Bachelor's degree in Chemical Engineering, Biotechnology Engineering, or another related fielc
• 0-1 years of engineering or other relevant technical work experience

Preferred Requirements:

• Experience working in a cGMP environment or other highly regulated
  industry
• Prior experience with mammalian cell culture processes

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).