Facilities Engineering Compliance Coordinator

Facilities Engineering Compliance Coordinator

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 (02 years) with training and mentorship provided.

Essential Functions:

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.

Compliance:

• 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 on-the-floor resource by referencing SOPs, checking documentation for completeness, confirming CMMS steps are followed, and promptly escalating questions/issues to SMEs or supervisors.
• Support internal/external audit readiness for Facilities Engineering areas: prepare evidence, track actions, and verify timely closure.
• Deviation and CAPA Management
• Draft records under guidance
• Assist in drafting deviation and CAPA records under SME/QA guidance by compiling facts, logs, and evidence from CMMS/BMS/EMS and related sources.
• Write clear problem statements, define scope, and perform accurate, right?first?time data entry using GDP.
• Investigations for Facilities/Utilities events
• Support investigations for Facilities/Utilities events (e.g., HVAC, SCADA, PW/WFI, clean steam, compressors) by scheduling meetings, preparing agendas, capturing notes, and updating records.
• Gather system histories, alarms, trends, and maintenance/calibration history; attach supporting evidence to the record.
• Root cause analysis (with guidance)
• Contribute to RCA using structured tools (5?Why, Fishbone, 6M, FMEA/Fault Tree when applicable); document root and contributing factors and proposed actions.
• Differentiate causes from symptoms and consider human/system factors (procedures, training, methods, environment, equipment, materials).
• Workflow, approvals, and closure
• Route records for QA/SMEs review, monitor due dates, and follow up to keep work on track.
• Set up effectiveness checks where required and ensure closure criteria are defined and met before record closure.
• Escalation and communication
• Promptly escalate potential quality or regulatory issues to supervisors/SMEsespecially those impacting product quality, equipment/utilities reliability, or complianceand document the escalation per procedure.

Other:

All other duties as assigned.

Required Skills & Abilities:

• Basic understanding of cGMP and how it applies to Facilities/Utilities and Quality systems (maintenance, calibration, qualification, change control, deviations/CAPA/effectiveness checks); willing to learn site procedures and tools.
• Strong data integrity habits and Good Documentation Practices (accurate, legible, timely entries; version control).
• Clear, professional written and verbal communication; collaborates well across Engineering, EHS, Quality, and Operations.
• Knows when to escalate; seeks SME/QA guidance appropriately and documents escalations
• Able to manage multiple tasks, prioritize with guidance, and meet deadlines.
• High attention to detail and reliable follow-up to drive on-time record closure.
• Analytical and digital skills
• Basic analytical/data review skills; comfortable interpreting logs, trends, and checklists.
• Proficient with Microsoft 365 (Outlook, Word, Excel, PowerPoint); can build clean trackers and simple reports (filters, basic pivots, charts).
• Exposure to Facilities Engineering practices (PMs, calibrations, change control) and interest in growing technical knowledge.
• Prepared to occasionally work off-hours (alternate shifts/weekends) to support audits, investigations, or Facilities Engineering activities that require compliance oversight.
• Assist in preparing concise presentation materials for cross-functional review boards (e.g., DRB, CRB, CCRB, DMRB, QRB); attend and take notes as needed.

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 accommodation 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:
• Stand for extended periods; bend, stoop, push/pull, reach overhead.
• Use hand-eye with sufficient coordination and dexterity for computers and office equipment.
• Lift up to 25 pounds frequently and up to 50 pounds occasionally.
• Maintain regular on-site attendance at the FLBT facility (on-site presence is mandatory).
• Comfortable working in classified/mechanical/manufacturing/utility areas with PPE, with occasional exposure to noise, moving equipment, and temperature changes.
• Support occasional off-hours work (evenings/weekends) for operations or emergent issues.

Qualifications:

Bachelor's Degree in Engineering, Life Sciences, and/or related field; up to two (2) years of experience in a regulated environment (Pharma, Biotech, Medical Devices) Recent grads are welcomed.

Preferred Qualifications:

Exposure to GMP facilities/utilities (e.g., HVAC, SCADA, PW/WFI, clean steam, compressed air/gases) through coursework, labs, internship, co-op, or entry-level roles. Familiarity with basic root cause tools (5-Why, Fishbone/Ishikawa) and risk tools (FMEA). Certifications in reliability, quality, or maintenance (e.g., Six Sigma Yellow Belt, CMMS). Comfort with technical documentation (SOPs, Drawings) and Good Documentation Practices. Eager to learn the regulations and standards relevant to our environment, grow professionally, and adopt our way of working in a fast-paced pharma / biotech business. Candidates who are inspired to enhance people's health and quality of life and who value integrity, collaboration, and continuous improvement are strongly encouraged to apply.

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