CQV/Validation Engineer (cGMP - Pharmaceutical)

Company: AM Technical Solutions, Inc
Location: Worcester
Posted on: August 7, 2022

Job Description:

CQV/Validation Engineer (cGMP - Pharmaceutical)Multiple Locations - USA Summary:AM Technical Solutions is looking for multiple CQV resources to support major projects for various pharmaceutical clients in the Boston, MA and Southern NH areas (or other locations depending on interest). This individual will write and execute validation protocols for new and existing, facility utilities, and process equipment. AMTS has opportunities throughout the country and overseas supporting multiple locations in MA, NH, RI, NC, Europe, and other locations. Responsibilities: - Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes. - Start-up C&Q experience of process and utility systems. - Be able to work as part of a large project team and be a system owner for a system. - Role will involve authoring and executing CQV documentation for a defined system against project schedule and timelines. - Deviation/Nonconformance write up and close out resolution. - Provide direction, input, review and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems, and utilities to ensure thoroughness, accuracy and compliance with company policies. - Provide technical troubleshooting and creative solutions to manufacturing process challenges. Qualifications: - Bachelor's degree (preferably in an engineering discipline) or relevant engineering, scientific or related discipline. - 3+ years professional experience in a biologics/pharmaceutical. - Experience developing and executing process, equipment, and cleaning validation protocols. - Knowledge of cGMP practices and standards. - Excellent written and verbal communication and interpersonal skills; prefer an individual with a positive, results oriented, team mindset and capable of changing direction and focus as priorities shift.

Keywords: AM Technical Solutions, Inc, Worcester , CQV/Validation Engineer (cGMP - Pharmaceutical), Healthcare , Worcester, Massachusetts