Manati, Puerto Rico | Posted on 09/02/2026 We are seeking an experienced CSV/Decommissioning Specialist to support decommissioning activities for laboratory instruments and associated utilities (glass washer/utilities, glass dryer/utilities, injection measuring system, and balance), and the development of retirement package and CSV deliverables. Key Responsibilities: Manage end-to-end decommissioning of GMP equipment, instruments, and computerized systems. Lead change control, documentation, compliance, and retirement activities. Coordinate cross-functional efforts with Quality, IT, Maintenance, EHS, Engineering, Finance, and Operations. Ensure proper asset disposition, record retention, data archival, and regulatory compliance. Execute and close qualification, validation, and decommissioning documentation according to site procedures and GMP standards. Requirements BS or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline. More than Five (5) years of experience validating laboratory computerized systems in a manufacturing environment , and training in validation methodologies, technologies, and process control computer systems Knowledge on computerized system with data collection software (database). Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations Experienced in Laboratory Instrument Decommissioning execution. At least three (3) years of experience working with PLC’s, Industrial Computers or laboratory instrumentation systems . Background in pharmaceutical products manufacturing environment . Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications #J-18808-Ljbffr
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