Sr. Compliance Manager, Facilities Engineering

Position Overview

Summary: The Facilities Engineering Sr Compliance Manager will provide strategic leadership for Facilities Engineering compliance across GMP utilities, equipment, and infrastructure. Oversees Deviation / CAPA / Effectiveness Check / Change Control processes while driving continuous improvement, risk mitigation, and a sustained state of control in alignment with regulatory and internal standards. Lead and direct the Facilities Engineering Compliance team while partnering with QA, Manufacturing Operations, Validation, Engineering, Automation, QC Microbiology, and EHS. 

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Essential Functions: 

Responsible for leading / managing the following activities within the Facilities Engineering Department: 

Compliance 

• Own the Facilities Engineering compliance program, policies, and procedures.  

• Oversee initiation, investigation, and closure of Facilities/Engineering deviations and events; ensure timely closure, robust RCA, and QA-aligned outcomes. 

• Direct/root cause analysis and approve impact assessments (product/patient, equipment/utilities, data integrity); ensure traceable linkage to CAPA and change control. 

• Support change control process for equipment, utilities, and infrastructure; apply formal change control and risk assessment. In addition to the implementation, execution, documentation, and review of CAPAs and Effectiveness Checks. 

• Maintain controlled procedures (SOPs), work instructions, and forms for Facilities Engineering; ensure periodic review is completed on time.  

• Establish, track, and report KPIs/metrics for deviations, CAPAs, change controls, and effectiveness checks; publish dashboards, trends, and action plans. 

• Trend recurring issues: implement systemic fixes and verify effectiveness to prevent recurrence. 

• Support the Facilities Engineering department during internal and external audits with acceptable state of readiness and compliance per FLBT Site requirements.  

• Partner with Validation/Automation/Engineering on commissioning, qualification, requalification, and change impact; ensure alignment with URS, design standards, and regulatory expectations. 

Deviation Investigation and CAPA Management 

• Lead deviation/event investigations using structured RCA methods (e.g., 5‑Whys, Fishbone, FMEA); coach investigators to identify true root and contributing causes.    

• Perform and/or review initial containment and impact assessments.   

• Promptly escalate and notify Management/QA of potential quality or regulatory risks; initiate interim controls and communicate status until closure. 

• Author and approve investigation reports that meet quality standards; ensures evidence collection, data integrity, and traceable linkage to CAPAs and change controls. 

• Define, implement, and verify corrective and preventive actions; perform effectiveness checks and close CAPAs on time. 

• Trend deviations/events to identify systemic issues; drive continuous improvement initiatives to reduce recurrence and improve process capability. 

• Partner with cross-functional SMEs (QA, EHS, Maintenance, Validation, Operations) to ensure holistic impact assessment and robust CAPAs. 

People Leadership and Collaboration 

• Lead, coach, and develop a hi