CSV/Decommissioning Specialist

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
• Bilingual (both English/Spanish)