Sr Compliance Specialist, Facilities Engineering

About the role

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 checks, 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.

Responsibilities

• 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
• 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 Checks, and Change Controls 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 Checks
• Support Compliance Coordinators with Facilities Engineering documentation and systems (CMMS/SCADA)
• Support 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 Controls
• 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
• Author 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
• Perform all other duties as assigned

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)

Required Skills

• 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-functional 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)

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

Working Conditions & Physical Requirements

• 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