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 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.

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.
• 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).
• 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.

Requirements

• 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.
• Able to manage multiple priorities and adapt to changing demands in a fast-paced environment.
• 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).

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).