Sr Compliance Specialist, Facilities Engineering

Position Overview

Summary :
The Sr Compliance Specialist - Facilities Engineering, ensures that facilities, utilities, and critical systems operate in full compliance with applicable regulations, codes, and internal quality standards. This role leads and manages deviations, corrective/preventive actions (CAPA’s), effectiveness check, and change controls; maintains robust documentation and training programs. The Sr Compliance Specialist partners with Engineering, EHS, Quality, and Operations to sustain a state of control, optimize compliance processes, and ensure timely closure of records.

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:

Essential Functions:

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

• Collaborate with Facilities Engineering Department staff and site leadership to build a strong quality culture by coaching on GMP principles and the rationale behind them, modeling and reinforcing compliant behaviors in daily operations.

Compliance

• Intake and triage deviations for criticality, impact, and regulatory significance.
• Ensure proper record classification, ownership, and timelines per FLBT - QMS requirements.
• Lead and facilitate cross – functional root cause analysis (RCA) workshops using structured tools (5-Why, Fishbone, FMEA, Fault Tree, 6M); validate root cause with data, and execute confirmatory tests / analysis as needed
• Distinguish true root causes from symptoms; assess human and system factors.
• Lead the on-time, compliant closure of Deviations, CAPAs, Effectiveness Check and Change Control for Facilities Engineering.

• Initiate deviations, CAPAs, effectiveness checks, and change controls upon request, ensuring compliance and timely progression.
• Support Internal and External Audit readiness regarding Facilities Engineering Areas.
• Support Facilities Engineering Compliance Coordinators with the initiation, investigation, implementation, and execution of deviations, CAPAs, and Effectiveness Check.
• Support Compliance Coordinators with Facilities Engineering documentation and systems (CMMS/SCADA).
• Supports assignment of deviation workload within the Facilities Engineering Compliance Team
• Support the generation and sustainability of KPIs around timely closure of records, and the status of deviations, CAPA’s, Effectiveness Checks and Change Control.
• Coach Compliance Coordinators/Specialists to achieve 100% on-time closure of all quality related investigations and QMS Records.
• Mentor investigators and improve first-pass quality;
  Provide training and support to the Compliance Coordinators / Specialists.
• Author/revise SOPs, work instructions, forms and related training in the eQMS.
• Review URS, IQ/OQ/PQ protocols and reports for Facilities Engineering supporting areas, equipment, utilities, and systems

Deviation and CAPA Management

• Author for high-quality deviation and CAPA records, including clear problem statements, root causes and contributor factors, impact/risk assessment, defined corrections / CAPAs, and effectiveness checks, in addition to…