Manager

Description:

FUJIFILM Biotechnologies is seeking a highly skilled CSV Manager to oversee the management, scheduling, and compliance of GxP-regulated computerized systems across multiple state-of-the-art manufacturing buildings (NCTM, TBF-100, FBF-200, FBF-300) at its College Station, Texas facility. This leadership role ensures that all computerized system lifecycle activities comply with regulatory requirements, data integrity standards, and Computer Systems Validation (CSV) procedures.

The CSV Manager will be responsible for maintaining and updating System Master Lists, requalification schedules, and overseeing validation engineers and specialists in daily validation activities. They will provide oversight of validation planning, execution, and documentation while coordinating with cross-functional teams to support manufacturing, quality, and compliance objectives.

Key responsibilities include:

• Leading scheduling, prioritization, and supervision of validation activities across multiple facilities.

• Reviewing and approving validation deliverables such as protocols, plans, risk assessments, installation/operational qualifications, traceability matrices, and final reports.

• Ensuring compliance with global regulatory standards including 21 CFR Part 11, Annex 11, GAMP5, and Data Integrity guidelines.

• Creating, reviewing, and updating SOPs, templates, and related validation documentation.

• Overseeing the work of internal validation staff and contractors to ensure timely completion of validation projects.

• Providing expertise on the System Delivery Life Cycle (SDLC) deliverables and ensuring quality standards are met.

• Coordinating with project teams to evaluate which system elements require validation and conducting impact assessments for system changes.

This is an excellent opportunity for a validation professional with strong leadership skills to join a global biopharmaceutical company dedicated to advancing vaccines, cell therapies, and gene therapies.

Company Overview:
FUJIFILM Biotechnologies is a global leader in biopharmaceutical innovation, collaborating with industry leaders to deliver life-changing therapies. With a state-of-the-art biomanufacturing facility in College Station, TX, the company combines small-town charm with modern infrastructure, innovation, and growth opportunities. Guided by FUJIFILM’s purpose of “giving our world more smiles,” the organization offers a mission-driven, collaborative culture where employees are empowered to make a meaningful impact.

Qualifications:

• Master’s in Engineering or Science with 5+ years validation experience OR Bachelor’s with 7+ years.

• 4+ years supervisory experience.

• Strong knowledge of validation in pharmaceutical/biotech FDA-regulated environments.

• Hands-on knowledge of DeltaV or similar automation platforms.

• Excellent technical writing, oral communication, and organizational skills.

• Ability to manage teams, projects, and documentation with minimal supervision.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Physical Requirements:

• Ability to perform prolonged sitting, occasional bending, stooping, stretching, and ladder work.

• Manual dexterity for operating office equipment and test equipment (e.g., temperature loggers, fog machines, air sampling equipment).

• Regular, reliable attendance is mandatory.