AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
CQV/Validation Engineer (cGMP Pharmaceutical)
Massachusetts and New Hampshire Area
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. 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.
Direct Involvement Opportunities:
- 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, Skills, And Experience:
- Bachelors degree (preferably in an engineering discipline) or relevant engineering, scientific or related discipline.
- 3+ years professional experience in 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.