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:

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 high-performing Facilities Engineering Compliance team; set clear goals, conduct regular 1:1s, provide feedback/recognition, and manage performance and succession.

• Set priorities and allocate resources (people, time); manage capacity and workload, balancing planned work with emergent compliance needs.

• Drive cross-functional collaboration with EHS, Quality/QA, Operations, Maintenance, Procurement, Security, and IT; align on priorities, remove blockers, and ensure timely decision-making.

• Ensure role-based training compliance.

• Foster a culture of safety, inclusion, accountability, compliance, and continuous improvement; promote knowledge sharing and standardization.

• Partner with HR/L&D on technical competency frameworks and career development for compliance roles.

• Support FLBT Compliance Initiatives

Other

• Perform other related duties as assigned to support business and compliance objectives.

Required Skills & Abilities:

• Excellent oral and written communication skills, interpersonal and organizational skills.

• Excellent organizational, analytical, data review, and report writing skills.

• Practical understanding of equipment used in bioprocessing (downstream and/or upstream).

• Proficient user of deviation management systems such as TrackWise

• Proficient with Microsoft Office applications.

• Good self-discipline and attention to detail.

• Must have flexible work hours - must be willing to work outside of normally scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.

• Ability to multitask and easily prioritize work.

• Ability to work independently with little supervision.

• Experience working in the pharmaceutical industry.

• Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the facility.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, bending, stooping, pushing, pulling, reaching above shoulders and stretching.

• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.

• Lift up to 25 pounds frequently and up to 50 pounds, on occasion.

• Attendance is mandatory.

Qualifications:

• Bachelor's Degree in an Engineering discipline or Life Science. Eight (8) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or Compliance role; OR

• Associate degree and ten (10) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.; OR

• High School Diploma or GED and twelve (12) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.

• A minimum of five (5) or more years of previous leadership experience.

Preferred Qualifications:

• Experience managing end-to-end processes for Deviations, CAPAs, Effectiveness-Check and Change Controls.

• Technical writing and SOP development; ability to interpret P&IDs, URS, Validation protocols/Summary Reports; comfortable in classified areas/mechanical spaces.

• Understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream)
• Knowledgeable in Data Integrity and ALCOA++ per 21CFR Part 11/220/221

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected] or (979) 431-3500).