Validation Specialist IV

Equipment Validation Specialist

Newington, NH – $64,800.00–$81,000.00

The Equipment Validation Specialist ensures all critical GMP equipment and systems are validated, maintained, and compliant with user requirements, process parameters, and global regulatory guidelines. The role provides Operations, Quality Assurance, and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required, securing a quality, compliant manufacturing environment.

• Perform Equipment Validation activities, including Validation Maintenance Quality Systems review and requalification to keep GMP equipment in a validated state.
• Program, organize, and maintain Validation equipment and supplies, including data loggers and probes.
• Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms, and Equipment.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
• Perform assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and Track Wise Quality System (Change Control, Deviation, CAPA).
• Perform other duties as assigned.

• 4‑year degree strongly preferred.
• 4 years’ experience in manufacturing.