Senior Validation Engineer - Biotech Systems Lead

FUJIFILM Holdings America Corporation; College Station (TX); On-site; USD 90,000 - 128,000; Full time

Job summary

FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, TX seeks a Sr. Validation Engineer to provide scientific and technical support for product launches, technology transfers, and new technology introductions.

The role leads validation lifecycle activities (CD, IQ/OQ/PQ), mentors junior engineers, and collaborates across functions to ensure GMP compliance, timely delivery, and quality documentation.

Qualifications

• Experience in validation engineering in pharma/biotech.
• Ability to plan, execute and document validation life cycle activities.
• Experience mentoring validation engineers.
• Familiarity with ISPE Baseline 5, GMP, GDP, GLP guidelines.
• Knowledge of validation reports and regulatory requirements.

Responsibilities

• Lead validation projects from protocol to final report.
• Coordinate cross-functional validation activities and schedules.
• Develop and review SDLC deliverables and VPPs.
• Mentor junior staff and manage project teams.
• Ensure compliance with regulatory standards and SOPs.

Skills

Project management

Mentoring

Cross-functional leadership

Documentation

Regulatory compliance

Vendor collaboration

Education

Master's degree in Mechanical Engineering

Bachelor's degree in Mechanical Engineering

Tools

HPLC

UPLC

UV-Vis spectroscopy

pH meters

Single Use Technology

Sterilization equipment

Job description

FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, TX seeks a Sr. Validation Engineer to provide scientific and technical support for product launches, technology transfers, and new technology introductions.

The role leads validation lifecycle activities (CD, IQ/OQ/PQ), mentors junior engineers, and collaborates across functions to ensure GMP compliance, timely delivery, and quality documentation.