Manufacturing Expert (m/w/d) PFS
Core
Lead training activities and support implementation of aseptic filling lines for Pre-Filled Syringes (PFS) in sterile manufacturing environments.
Role type
Senior Manufacturing Expert (Aseptic Filling)
Builds
Aseptic PFS filling lines and sterile manufacturing processes
Domain
Pharmaceutical manufacturing, Aseptic processing
Required skills
Aseptic filling process expertise, Media fill concept development, Single Use Equipment implementation, GMP compliance, CAPA management, Change control, Ramp-up support, Training design and delivery
Preferred skills
Bracketing strategies, Format implementation, Customer communication, Audit preparation
Technologies
Single Use Equipment, Media Fill systems, PFS filling lines
Responsibilities
Develop training concepts for sterile room staff, Collaborate on Media Fill concepts with Bracketing strategies, Support implementation of Single Use Equipment, Assist in ramp-up of new PFS filling lines, Conduct and update training/practical training for sterile areas, Participate in deviation investigations, CAPA, and Change processes, Support internal and external audits
Seniority
Senior, hands-on IC