Senior Manager, Commissioning Engineering
Core
Lead commissioning, vendor installation, and operational/performance qualification of systems for clinical and commercial manufacturing facility capital projects.
Role type
Senior Manager, Commissioning Engineering
Builds
Commissioned and qualified manufacturing assets and systems for FDA-regulated facilities
Domain
Pharmaceutical manufacturing / Engineering validation
Required skills
Engineering project management, contractor management, vendor qualification, scheduling, factory acceptance testing, asset onboarding, team leadership, resource management, continuous improvement, technical writing, matrix environment leadership
Preferred skills
Equipment/facility/sterilization commissioning, critical utilities validation, temperature mapping, lean principles
Technologies
cMMS, P&IDs, Process Flow diagrams, SOPs
Responsibilities
Lead commissioning and qualification of systems; draft and oversee commissioning protocols and reports; manage multiple capital execution projects; develop and lead high-performance team; ensure alignment with industry guidelines and BMS directives
Seniority
Senior, hands-on IC with management responsibilities