The Facility Start-Up Manager will ensure operational readiness by managing the start-up of expanded clinical manufacturing zones and overseeing upgrades to existing production areas until they are handed over to routine clinical operations
Job Summary
The Facility Start-Up Manager will ensure operational readiness by managing the start-up of expanded clinical manufacturing zones and overseeing upgrades to existing production areas until they are handed over to routine clinical operations.
He/She will technically lead the start-up project team in a matrix organization and ensure that facilities and equipment meet sterile and device assembly production requirements, establish operational flows and ensure compliance with GMP, J&J/site policies and Annex 1.
The Facility Start Up Manager will ensure new equipment and processes are aligned with the commercial facility and maintain continuous harmonization between both to enable seamless scale-out and technical transfers.
Matching Summary
The Facility Start-Up Manager will ensure operational readiness by managing the start-up of expanded clinical manufacturing zones and overseeing upgrades to existing production areas until they are handed over to routine clinical operations.
Skills & Requirements
Must-have
aseptic filling technologies and processes
GMP regulated environment
sterile and device assembly production
operational readiness
technical lead of a cross-functional team
Nice-to-have
Agile Decision Making
Disruptive Innovations
Emerging Technologies
Inclusive Leadership
high customer and business orientation
Key Requirements
Master’s degree in engineering or scientific discipline