Sr. IT Engineer 1, CSV

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

 

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