Senior Manager, Commissioning Engineering
Core
Lead commissioning, vendor installation, and operational/performance qualification of systems for capital projects at a clinical and commercial manufacturing facility.
Role type
Senior Manager, Commissioning Engineering
Builds
Commissioned and qualified manufacturing assets and systems for clinical and commercial production
Domain
Pharmaceutical manufacturing / Engineering validation
Required skills
Engineering project management, commissioning program documentation, contractor management, vendor qualification, scheduling, factory acceptance testing, asset onboarding, team leadership, resource management, continuous improvement, technical writing, GMP qualification policies
Preferred skills
Equipment/facility/sterilization commissioning, critical utilities validation, temperature mapping, lean principles, matrix environment leadership
Technologies
cMMS, P&IDs, Process Flow diagrams, SOPs, automation systems, laboratory instrumentation
Responsibilities
Lead functions for commissioning and qualification of systems; Draft and oversee commissioning protocols and reports; Manage multiple capital execution projects; Develop and lead a high-performance commissioning team; Ensure alignment with industry guidelines and BMS directives
Seniority
Senior Manager, hands-on leadership with team development