Process Expert Sterile Production - Visp (Maternity Cover) e/v/e/r/y/o/n/e
Core
Subject matter expert for aseptic manufacturing processes, ensuring robust, compliant, and efficient production of sterile parenteral products.
Role type
Senior Process Expert (Sterile Production)
Builds
Sterile injectable treatments (fill-finish, filtration, sterilization, lyophilization)
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Aseptic manufacturing techniques, EU-GMP Annex 1 compliance, Root cause analysis, Validation and qualification, Statistical process control, GMP documentation, Technical troubleshooting
Preferred skills
Fill-finish technology, Lyophilization, Media-fill studies, Aseptic process simulations, Data analysis tools
Technologies
VHP, Filtration systems, Lyophilizers, Cleanroom systems
Responsibilities
Optimize aseptic production parameters and workflows, Investigate deviations and define CAPAs, Support product and process transfers, Conduct statistical evaluations of CPPs and CQAs, Act as technical representative during audits
Seniority
Senior, hands-on IC