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Facilities Engineering Compliance Coordinator

Job Location:

College Station, TX - USA

Monthly Salary: Not provided by the employer

Posted: 13 September 2026 (Yesterday)

Application Deadline: 11 December 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

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.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples 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 youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat 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 its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

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.

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 rightfirsttime 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 (5Why 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.

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:

Bachelors 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 peoples health and quality of life and who value integrity collaboration and continuous improvement are strongly encouraged to apply.

EEO Information

Fujifilm is committedto 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 ( or ).

Required Experience:

IC

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