Senior Validation Engineer

Equipment Validation Specialist III-IVLocation: 101 International Drive, Portsmouth, NH 03801Duration: 12-month contract with potential for extension or conversionShift: Standard Business HoursPay Rate: $50hour to $80hour depending on the experience!Our client is a leading provider of manufacturing and development services for the pharmaceutical, biotech, and specialty ingredients industries. They specialize in producing active pharmaceutical ingredients, cell and gene therapies, and microbial control solutions for various markets, including healthcare and consumer goods. With a strong focus on innovation and sustainability, our client supports businesses in bringing high-quality, science-driven products to the market efficiently and safely. Job Summary:Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance 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 so they can be assured of a quality, compliant manufacturing environment. Job Description:Provide Subject Matter Expert support with Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.Driveown the validation plans and execution of equipment changes and process improvements.Execution of Installation QualificationsOperational Qualifications and drafting Performance Qualifications as required.P erfor m Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.P r og ram, organize, and maintain Validation equipment and supplies including dataloggers and probes.Demo nstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IVIQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.Dev elop validation protocols from plans and engineering documents.P r ov ide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etcP erfor m assigned Quality Systems activities within Document Ma nagement System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA) Job Qualifications:Bachelor's Degree5-10 years of relevant experienceStrong understanding of GMP regulations, FDA guidelines, and industry standards (ICH, ISO, ASTM, USP).Experience with validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Created: 2025-02-23