What are the responsibilities and job description for the CQV/Validation Engineer (cGMP - Pharmaceutical) position at AM Technical Solutions?
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 US. 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.
- 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 :
