Senior CQV Engineer
Core
Lead engineering activities for manufacturing equipment and processes in a regulated biomanufacturing environment.
Role type
Senior CQV Engineer
Builds
Manufacturing equipment and processes for medicines and life sciences therapies
Domain
Life Sciences / Biomanufacturing / GMP
Required skills
Engineering degree, GMP knowledge, validation principles, equipment troubleshooting, process design, change control, risk assessment, technical documentation
Preferred skills
Mentoring, cross-functional collaboration, problem-solving
Technologies
Manufacturing equipment, validation systems
Responsibilities
Lead engineering activities supporting research, operations, facilities, and capital projects; Troubleshoot equipment and systems while driving continuous improvements; Design, improve, commission, and qualify manufacturing equipment and processes; Prepare and review engineering documentation, protocols, reports, and standard operating procedures; Support change controls, validation activities, and compliance with GMP requirements; Partner with cross-functional teams to assess risks and improve system reliability and performance; Support manufacturing operations to ensure safe, reliable, and efficient production
Seniority
Senior, hands-on IC