FUJIFILM Biotechnologies
Sr. IT Engineer 1, CSV
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
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Sr. IT Engineer 1, CSV
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FUJIFILM Biotechnologies 1 day ago Be among the first 25 applicants Join to apply for the
Sr. IT Engineer 1, CSV
role at
FUJIFILM Biotechnologies 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 (FDBN_PNC@fujifilm.com). Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x Get notified about new Senior Information Technology Engineer jobs in
Holly Springs, NC . North Carolina, United States $99,300.00-$137,700.00 1 week ago North Carolina, United States 3 weeks ago Durham, NC $120,000.00-$235,750.00 1 day ago Raleigh, NC $1,000.00-$2,000.00 2 months ago Software Engineer ( Fullstack - .NET/C#/Angular)
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Sr. IT Engineer 1, CSV
role at
FUJIFILM Biotechnologies 1 day ago Be among the first 25 applicants Join to apply for the
Sr. IT Engineer 1, CSV
role at
FUJIFILM Biotechnologies 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 (FDBN_PNC@fujifilm.com). Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x Get notified about new Senior Information Technology Engineer jobs in
Holly Springs, NC . North Carolina, United States $99,300.00-$137,700.00 1 week ago North Carolina, United States 3 weeks ago Durham, NC $120,000.00-$235,750.00 1 day ago Raleigh, NC $1,000.00-$2,000.00 2 months ago Software Engineer ( Fullstack - .NET/C#/Angular)
Raleigh, NC $130,000.00-$170,000.00 20 hours ago North Carolina, United States $101,150.00-$150,700.00 2 hours ago North Carolina, United States 4 months ago North Carolina, United States $125,000.00-$145,000.00 1 month ago Sr. Software Engineer, Full-Stack - Slack
Raleigh, NC $86,500.00-$164,350.00 1 month ago Raleigh, NC $85,000.00-$225,000.00 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr