Sr Computer System Validation (CSV) IT Engineer-Pharmaceutical

FUJIFILM Biotechnologies

Raleigh (NC)

On-site

USD 130,000 - 170,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading biopharmaceutical company in Holly Springs, North Carolina seeks a Sr. IT Engineer 1, CSV. This role involves ensuring compliance with Computer System Validation for IT systems and collaborating across teams to enhance operational efficiencies. Ideal candidates have a Bachelor's in relevant fields and significant CSV experience in cGMP environments, along with leadership skills. A dynamic workplace culture awaits you in a perfect blend of community and opportunity.

Qualifications

5 years of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations.
Prior experience leading projects and/or teams.
Master’s degree preferable with 3 years of experience.

Responsibilities

Ensures high standard CSV within budget.
Supports document and process development for CSV.
Maintains validation status of large scale IT systems.

Skills

Effective communication

Collaborative attitude

Analytical detail

Problem-solving

Ability to lead

Knowledge of Kneat validation software

Ability to travel

Education

Bachelor’s degree in Chemical Engineering or related fields

Tools

Kneat validation software

Job description

Direct message the job poster from FUJIFILM Biotechnologies

#35288-Sr. IT Engineer 1, CSV - Holly Springs, NC

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

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.

Seniority level