Sr. IT Engineer 1, CSV

Fujifilm

Posted on : 14-08-2025

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1 Vacancy

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Job Location

Holly Springs, MS - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 14-08-2025

Job Description

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

Ensures that CSV is conducted in a consistently high standard within budget and that objectives are met on time for the companys 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 FDBs 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

Bachelors 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

Masters 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 tominutes)
Ability to sit for prolonged periods of time. No X Yes 60 frequency/minutes (If yes may specify frequency/duration: up tominutes)
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 committedto 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 ().

Required Experience:

Senior IC

Employment Type

Unclear

Company Industry

Key Skills

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About Company

Fujifilm

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Sr. IT Engineer 1, CSV

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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