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Position Overview

The Sr. IT Engineer 1, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation, maintains a validated state, with a focus on consistent policy administration. Additionally, this role works closely with other workstreams at FDBN and IT departments at other locations to align strategies and procedures. This role facilitates improvement initiatives, supports regulatory agency, and third-party inspections, as needed.

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

+ Ensures that CSV is conducted in a consistently high standard, within budget, and that objectives are met on time for the company's objectives

+ Provides plans for the qualification of IT Computerized Systems used across the site.

+ Supports the development of documents, processes, and procedures of the CSV program

+ Generates, reviews, and approves Manufacturing and IT Computerized Systems lifecycle documentation (e.g., risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports)

+ Maintains the validation status of Manufacturing and IT Computerized Systems

+ Assists with managing the allocation of contract CSV resources and monitors the quality of their deliverables to support local IT projects

+ Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices

+ Coordinates with Computer System vendors, as needed

+ Assesses the impact of Computer System modifications and maintains change control

+ Works with the global CSV team to produce high quality deliverables aligning to FDB’s IT Quality Management Systems (QMS)

+ Identifies and drives process improvement and implementation ideas to improve efficiencies

+ Other duties, as assigned

Knowledge and Skills

+ Effective communication, both written and verbal

+ Collaborative attitude working with global peers and cross-functional teams toward company and department goals

+ Ability to prioritize and work autonomously based on common goals and objectives

+ Strong analytical detail and problem-solving

+ Ability to lead through assignment of work tasks, development of project schedules, and management of timelines

+ Knowledge of Kneat validation software, IT Systems, including basic software and hardware principles, implementation options (on prem, cloud, etc.) and validation methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11

+ Ability to travel domestic and international, up to 10%

Basic Requirement

+ Bachelor’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 5 years of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations

+ Experience in Drug Substance Manufacturing (DSM), Drug Product(DP), and/or Finished Goods Manufacturing (FGM)

+ Prior experience leading projects and/or teams

Preferred Requirements

+ Master’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 3 years of direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations

+ Prior experience working in a CDMO environment

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern audible cues. X No Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes

Ability to stand for prolonged periods of time. No X Yes 60 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to sit for prolonged periods of time. No X Yes 60 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X 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. X No Yes

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 ([email protected]).

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _1 month ago_ _(8/11/2025 11:38 AM)_

**_Requisition ID_** _2025-35288_

**_Category_** _Information Technology_

**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_