CSV Automation Engineer 2

FUJIFILM Biotechnologies; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in Holly Springs, North Carolina is seeking a candidate for the Automation role, responsible for Computer System Validation and lifecycle documentation. The ideal candidate holds a Bachelor’s degree in Engineering and has relevant experience in Automation. Join us to transform healthcare while enjoying a dynamic and purposeful work environment.

Qualifications

• 2 years of Automation, Instrumentation & Controls or relevant technical experience.
• 3+ years of Automation experience preferred.

Responsibilities

• Ensure high standards in Computer System Validation.
• Provide plans for the qualification of the DSM area.
• Generate and approve lifecycle documentation.
• Maintain validation status of Automation systems.

Skills

Effective communication

Strong problem-solving skills

Ability to present information

Knowledge of Automation

Education

Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering

Job description

Direct message the job poster from FUJIFILM Biotechnologies

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

• Ensures that Computer System Validation is performed to a consistently high standard, within budget, and that objectives are met on time
• Provides plans for the qualification of the DSM area
• Participates in the development of documents, processes, and procedures of the CSV program
• Generates, reviews, and approves DSM Automation Computerized Systems lifecycle documentation (e.g. risk and impact assessments, requirement specifications, functional specifications, traceability matrices, commissioning and qualification protocols, validation plans, and validation summary reports)
• Helps to assess the impact of Computer System modifications through the change control process
• Helps to maintain the validation status of DSM Automation Computerized Systems
• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices
• Serves as on‑call support for CSV Automation inquiries and troubleshooting
• Other duties, as assigned

Knowledge and Skills

• Effective communication, both written and oral
• Strong problem‑solving skills
• Ability to effectively present information to others
• Ability to interpret and demonstrate knowledge of an Automation subject area to internal partners

Basic Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field 2 years of Automation, Instrumentation & Controls, or other relevant technical experience

Preferred Requirements

• 3+ year of Automation experience

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.