Biomedical Equipment Technician

Job Title : Equipment Validation Specialist III-IV

Location : 101 International Drive, Portsmouth, NH 03801

Duration : 12-month contract with potential for extension or conversion

Shift : Standard Business Hours

Pay Rate : $50 / hour to $80 / hour, depending on 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 :

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

Job Description :

• Provide subject matter expert support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.
• Drive and own the validation plans and execution of equipment changes and process improvements.
• Execute Installation Qualifications (IQ) and Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as required.
• Perform Equipment Validation activities, including Validation Maintenance Quality Systems review and requalification, ensuring GMP equipment remains 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, and Temperature Mapping of controlled storage rooms and equipment.
• Develop validation protocols based on plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, protocols, change controls, deviations, CAPAs, etc.
• Perform assigned Quality Systems activities within the Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA).

Job Qualifications :

Salary : $50 - $80