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.

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 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 collecting supporting evidence.
• Lead and/or support deviation/event investigations; facilitate root cause analysis and document contributing factors.
• Secure required Quality and Management approvals; drive on-time completion of investigations and alignment on corrective and preventive actions with stakeholders.
• Escalate potential quality or regulatory issues promptly, particularly those affecting product quality, equipment/utilities' reliability, or regulatory compliance.

Other

• All other duties as assigned.

Required Skills & Abilities:

• Strong working knowledge of cGMP regulations and their application to Facilities Engineering Quality Management Systems in the pharmaceutical industry (e.g., maintenance, calibration, qualification/validation, change control, deviations/CAPA/effectiveness check).
• Excellent written and oral communication, interpersonal, and organizational skills.
• Advanced, analytical, data review, and technical writing/reporting skills.
• Deep understanding of cGMP Facilities Engineering practices and requirements.
• Proficient with deviation management systems (e.g., TrackWise).
• Proficient with quality document control systems (e.g., Veeva).
• Proficient with Microsoft Office applications (Excel, Word, PowerPoint, Teams).
• Strong self-discipline, follow-through, and attention to detail.
• Flexible schedule: willing to work outside standard hours, including alternate shifts and weekends as needed.
• Ability to manage multiple priorities and adapt to changing demands in a fast-paced environment.
• Able to work independently with minimal supervision and collaborate effectively across functions and levels.
• Effective planning and organization skills; comfortable collaborating with colleagues at all levels across the FDB network.
• Clearly escalates and communicates issues across all governance levels.
• Develop and deliver presentations to cross - functionals review boards; Deviation Review Board (DRB), CAPA Review Board (CRB), Change Control Review Board (CCRB), Document Management Review Board (DMRB), and Site Quality Review Board (QRB).

Working Conditions & Physical Requirements:

The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform these functions.

While performing the duties of this job, the employee is regularly required to:

• Stand for prolonged periods; bend, stoop, push, pull, reach above shoulders and stretch.
• 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.
• Maintain regular on-site attendance at the FLBT facility (on-site presence is mandatory).
• Work in manufacturing/utility areas with PPE and occasional exposure to noise, moving equipment, or temperature variations.
• Navigate mechanical spaces, stairs, and ladders; walk/stand on concrete floors for extended periods.
• Work outside standard hours, including evenings/weekends, to support operations or respond to any emergent issue.

Qualifications:

• Bachelor's Degree (Engineering, Life Sciences, or related field) and eight (8) years' experience in pharmaceutical or other regulated industry (Biopharma, Medical Devices, or GxP Environments), preferably in Quality Assurance / Compliance role supporting Facilities/Utilities/Engineering; OR
• Master's Degree (Engineering, Life Sciences, or related field) and six (6) years' experience in pharmaceutical or other regulated industry (Biopharma, Medical Devices, or GxP Environments), preferably in Quality Assurance / Compliance role supporting Facilities/Utilities/Engineering.
• Equivalent combinations of education and experience will be considered (e.g., advanced degrees may offset years of experience)

Preferred Qualifications:

• Strong QMS Background: End-to-end processes for Deviations, CAPAs, Effectiveness-Checks and Change Controls.
• Experience within Facilities/Utilities (HVAC, clean utilities such as CDA, WFI and pure steam; Maintenance/Calibration (CMMS), and Validation/Qualification (URS, IQ/OQ/PQ).
• Technical writing and SOP development; ability to interpret P&IDs, URS and Validation protocols/Summary Reports; comfortable in classified areas and mechanical spaces.
• Knowledgeable in Data Integrity, ALCOA++ principles and applicable regulations: 21CFR Part 11/220/221; cGMP, GDPs, and Regulatory Agencies (e.g. FDA, EMA).
• Experience with risk tools (FMEA, HACCP, 5 Why's, Ishikawa), data trending, and basic statistics; Lean/Six Sigma a plus.
• Experience supporting internal/external audits and health authority inspections.

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 (FDBTHR@fujifilm.com or (979) 431-3500).