Decomissioning Specialist

Decommissioning Specialist

The Decommissioning Specialist plans, coordinates, and executes the decommissioning of pharmaceutical manufacturing equipment, utilities, systems, and facilities in full compliance with GMP requirements, internal procedures, and regulatory expectations. This role works cross-functionally with Engineering, Validation, Quality Assurance, Facilities, EHS, and Operations to ensure safe and compliant asset retirement, facility modifications, and site transition activities, while maintaining accurate documentation and supporting quality and regulatory inspections.

• Plan and execute detailed decommissioning activities for manufacturing equipment, utilities, and facility systems in a GMP-regulated environment.
• Author, review, and approve decommissioning protocols, reports, risk assessments, retirement packages, and supporting GMP documentation.
• Use electronic document management and quality systems to create, manage, route, review, and close decommissioning and validation documentation.
• Coordinate equipment shutdown, isolation, disconnection, removal, and disposal activities to ensure safe and compliant execution.
• Perform equipment and system assessments to determine decommissioning requirements, GMP impact, and quality and compliance risks.
• Support change controls, deviations, CAPAs, and quality records associated with decommissioning activities.
• Ensure proper archival and retirement of validation, maintenance, calibration, and other GMP records related to decommissioned assets.
• Collaborate closely with Validation and Quality teams to retire qualified and validated systems in accordance with site procedures.
• Coordinate contractors, vendors, and site personnel performing decommissioning work, ensuring alignment with project plans and safety requirements.
• Support EHS reviews and risk mitigation activities related to equipment and facility demolition, removal, or modification.
• Track project milestones, documentation status, and completion metrics using site quality systems and document management tools.
• Verify that all decommissioning activities are completed in accordance with GMP requirements, approved procedures, and project schedules.
• Explain decommissioning methodologies, documentation requirements, and GMP compliance expectations during audits and inspections.
• Manage multiple decommissioning work streams and documentation deliverables simultaneously, maintaining clear priorities and timelines.

• Experience decommissioning GMP manufacturing equipment, utilities, facilities, or validated systems within pharmaceutical, biotechnology, or life sciences environments.
• Hands-on experience authoring and managing decommissioning documentation packages, including protocols, reports, change controls, and risk assessments.
• Strong proficiency with electronic document management and quality systems for document authoring, review, approval workflows, and lifecycle management.
• Demonstrated knowledge of GMP regulations and their application to equipment and facility retirement activities.
• Working knowledge of Commissioning, Qualification, and Validation (CQV) lifecycle processes.
• Ability to assess quality and compliance impacts associated with decommissioning activities.
• Proven experience coordinating Engineering, Quality, Validation, Operations, and EHS stakeholders.
• Strong technical writing skills and meticulous document management capabilities.
• Ability to manage multiple concurrent work streams and documentation deliverables.
• Ability to clearly explain decommissioning methodologies, documentation requirements, and GMP compliance expectations during audits and inspections.
• Minimum 5+ years of experience in GMP pharmaceutical, biotechnology, or regulated manufacturing environments.
• At least 3 years of experience supporting decommissioning, validation, commissioning, qualification, or facility modification projects.
• Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Project.
• Experience working with CMMS platforms such as SAP PM or Maximo.
• Experience with Quality Management Systems such as Track Wise, Master Control, Veeva, or equivalent.
• Experience using Electronic Document Management Systems (EDMS).

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline is preferred; equivalent industry experience is considered.
• Familiarity with AutoCAD and ability to review facility drawings is preferred.
• Experience with commissioning, qualification, and validation activities in regulated manufacturing environments.
• Strong organizational skills and attention to detail in managing complex documentation and project timelines.
• Effective communication and collaboration skills for working with cross-functional teams and external partners.
• Ability to support risk assessments and EHS-related reviews for equipment and facility demolition or removal.

This is an onsite role in a GMP-regulated…