Facilities Engineering Compliance Coordinator

Position Overview

The Facilities Engineering Compliance Coordinator supports the compliant operation of facilities, utilities, and critical systems by coordinating documentation and follow-up for deviations, CAPA, effectiveness checks, and change controls. The role maintains data integrity, training acknowledgments, and record accuracy within applicable systems (e.g., CMMS, document control, quality systems). In collaboration with Engineering, EHS, Quality, and Operations, the coordinator sustains a state of control, drives audit readiness, and helps improve compliance workflows to achieve on‑time, right‑first‑time closures.

This is an entry‑level role (0-2 years) with training and mentorship provided.

The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission‑driven people like you who want to make a real difference in people's lives.

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive‑what we call Genki.

Our state‑of‑the‑art biomanufacturing facility is located in in College Station, Texas, which combines a small‑town feel with vibrant culture, top‑notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

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:

Responsible for the following activities within the Facilities Engineering Support Services function:

• Partner with Facilities Engineering to support a day‑to‑day culture of compliance by applying basic GMP principles, following SOPs and checklists, and promptly escalating questions or issues to the appropriate SME.

• Log deviation details, attach evidence, and perform initial screening for criticality, impact, and regulatory significance per site QMS. Propose preliminary record classification and route to the correct QA for review.
• Draft deviation and CAPA records under SME/QA guidance, including clear problem statements, scope, immediate containment, impact/risk assessments, root/contributing causes, and defined actions with due dates.
• Follow Good Documentation Practices (GDP) for accuracy, legibility, and data integrity.
  Participate in and, when appropriate, facilitate RCA using structured tools (5-Why, Fishbone/Ishikawa, FMEA, Fault Tree, 6M) under SME guidance.
• Differentiate true root causes from symptoms; consider human and system factors (procedures, training, methods, environment, equipment, materials).
• Generate simple trend charts; flag repeat issues and propose prevention‑focused improvements.
• Support the F&E QMS records workload by monitoring queues and escalating risks to due dates early.
• Coordinate QMS approvals; align corrective and preventive actions with stakeholders.
• Set up and/or execute effectiveness checks; ensure closure criteria are documented and met.
• Draft and revise SOPs, work instructions, forms, and related training materials; route through change control under SME/QMS review.
• Assist in authoring User Requirements Specifications (URS) for Facilities Engineering areas, equipment, utilities, and systems under SME guidance; aligning with safety, reliability, and compliance needs.
• Serve as an…