Facilities Engineering Compliance Coordinator

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

• 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/SMEs—especially those impacting product quality, equipment/utilities reliability, or compliance—and document the escalation per procedure.

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.
• 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.

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.