Associate Director, Commissioning and Start-Up Engineering (HAZOP)
Core
Provide operational leadership for commissioning, qualification, and start-up activities to ensure new manufacturing sites and facilities are delivered safely, compliantly, and ready for GMP operations.
Role type
Senior IC Associate Director, Commissioning and Start-Up Engineering
Builds
New manufacturing sites, facility expansions, utilities, and equipment systems
Domain
Pharmaceutical/Biotech manufacturing engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Commissioning and qualification strategy, HAZOP study leadership, GMP compliance, cross-functional team leadership, risk management, budget management, site walkdown execution, troubleshooting, operational readiness integration
Preferred skills
Facility expansion support, sterile injectables/biologics/API manufacturing experience, risk-based CQV methodology, digital turnover systems, global matrixed environment leadership
Responsibilities
Lead commissioning, qualification, and start-up activities across facilities and systems; Develop and execute HAZOP Studies for capital programs; Manage risks, dependencies, timelines, and budgets throughout the project lifecycle; Oversee site walkdowns against P&ID and equipment installations; Lead troubleshooting and corrective actions during startup; Integrate new assets into routine site operations.
Seniority
Senior, hands-on IC with strategic leadership
