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mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
The CSV & Decommissioning Specialist is responsible for leading and executing computerized system retirement and laboratory equipment decommissioning activities within a regulated pharmaceutical manufacturing environment. This role supports the planning, execution, documentation, and closure of decommissioning projects while ensuring compliance with cGMP requirements, Data Integrity principles, electronic records regulations, and internal quality systems.
Key Responsibilities
Position Summary
The CSV & Decommissioning Specialist is responsible for leading and executing computerized system retirement and laboratory equipment decommissioning activities within a regulated pharmaceutical manufacturing environment. This role supports the planning, execution, documentation, and closure of decommissioning projects while ensuring compliance with cGMP requirements, Data Integrity principles, electronic records regulations, and internal quality systems.
Key Responsibilities
- Lead the execution of computerized system and laboratory equipment decommissioning activities in compliance with applicable company procedures and regulatory requirements.
- Develop, manage, and support Change Controls associated with equipment, utilities, and computerized system retirement activities.
- Conduct impact assessments and risk evaluations to determine system retirement requirements and associated actions.
- Coordinate retirement and decommissioning activities for hardware, software, instrumentation, laboratory systems, and associated utilities.
- Execute and document decommissioning protocols, pre-approved test scripts, retirement plans, and validation activities.
- Coordinate data backup, archival, and retention activities to ensure long-term accessibility of electronic records and compliance with record retention requirements.
- Ensure electronic data, user accounts, methods, and system records are appropriately archived and retired following backup completion.
- Prepare, review, and execute CSV-related documentation, including retirement plans, validation reports, impact assessments, and final summaries.
- Support final periodic reviews to verify systems remained in a validated state through retirement.
- Coordinate cleaning, calibration, preventive maintenance, and closure activities for equipment scheduled for decommissioning.
- Ensure proper closure of Out-of-Tolerance (OOT) events and associated service requests when applicable.
- Coordinate the removal and inactivation of maintenance, calibration, and asset records within computerized maintenance management systems (CMMS).
- Manage documentation revisions associated with retired systems, including procedures, work instructions, forms, training materials, validation documents, and technical records.
- Coordinate spare parts disposition, relocation, inventory updates, and materials management activities.
- Support equipment disposal planning and execution while ensuring compliance with site safety, environmental, and asset management requirements.
- Coordinate equipment removal, shipping, warehouse transfer, and final disposition activities.
- Ensure engineering drawings, equipment master plans, and facility documentation are updated to reflect retired assets.
- Work closely with IT, Quality Assurance, Compliance, Engineering, EHS, Maintenance, and Operations teams during project execution.
- Prepare project status reports and provide updates to stakeholders throughout the project lifecycle.
- Ensure all project deliverables are completed and closed according to applicable quality and documentation standards.
- Bachelor's Degree or higher in: Computer Science, Information Systems, Engineering, Chemistry, Biology, Microbiology or related scientific/technical discipline
- More than five (5) years of experience in Computerized Systems Validation (CSV) within regulated manufacturing environments.
- Experience validating laboratory computerized systems and data acquisition software.
- Strong understanding of computerized systems, databases, software applications, and electronic records management.
- Experience executing laboratory equipment and computerized system decommissioning projects.
- Minimum of three (3) years of experience working with PLCs, industrial computers, laboratory instrumentation, or automated systems.
- Strong knowledge of: cGMP regulations, FDA requirements, 21 CFR Part 11, Data Integrity principles, Computerized System Validation methodologies
- Experience with change control, impact assessments, risk management, and validation lifecycle activities.
- Experience supporting data backup, archival, and retention processes.
- Strong technical writing and documentation skills.
- Proficiency in Microsoft Office applications including Excel, Word, and PowerPoint.
- Ability to manage multiple projects, priorities, and deadlines simultaneously.