Medical device or pharmaceutical manufacturing background
Fat sat equipment acceptance protocol execution
The role involves leading end-to-end device and packaging technology deployment projects within regulated manufacturing environments to enhance product robustness and efficiency
Job Summary
The role involves leading end-to-end device and packaging technology deployment projects within regulated manufacturing environments to enhance product robustness and efficiency.
Candidates must possess deep knowledge of medical device manufacturing processes including device assembly, sterilization, or packaging alongside strong supplier management skills.
Roche offers a culture that encourages personal expression and genuine connections where every voice matters in the mission to prevent, stop, and cure diseases.
Matching Summary
The role involves leading end-to-end device and packaging technology deployment projects within regulated manufacturing environments to enhance product robustness and efficiency.
Skills & Requirements
Must-have
7+ years technical project management experience
Medical device or pharmaceutical manufacturing background
FAT SAT equipment acceptance protocol execution
cGMP ISO 13485 FDA 21 CFR Part 820 knowledge
Supplier relationship management and selection
Technology lifecycle management from pilot to scale
Nice-to-have
PMP certification preferred
Automation MES systems familiarity
International travel willingness up to 25%
Strong negotiation and influencing skills
Fluent English communication abilities
Key Requirements
Bachelor's or Master's degree in Engineering or Science
7+ years of CAPEX project management experience
Experience with URS machine risk assessments C&Q strategies
Hands-on experience in at least two areas: Device Assembly Sterilization Packaging