Director, Commissioning and Start-Up Engineering

What you'll do

• Develop and execute commissioning, qualification, and start-up strategies for major capital projects and manufacturing expansions.
• Lead the execution of Hazard and Operability (HAZOP) studies for all capital programs.
• Conduct site walkdowns against as-built Piping & Instrumentation Diagrams to ensure equipment accuracy and operational readiness.
• Oversee readiness for utilities, process systems, cleanrooms, automation platforms, and supporting infrastructure.
• Drive operational readiness activities including SOP development, training, staffing, and maintenance planning.
• Manage third-party contractors and partners to ensure high execution quality and accountability.
• Ensure all commissioning and start-up activities comply with cGMP, regulatory, and EHS requirements.
• Serve as a senior escalation point for project risks, startup issues, and readiness gaps.

What we're looking for

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related technical discipline required; advanced degree preferred.
• Typically 20+ years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated environments.
• Extensive leadership experience in commissioning, qualification, validation, and plant start-up for complex facilities or capital projects.
• Demonstrated success leading large, cross-functional teams and managing multiple stakeholders in a matrixed organization.
• Strong knowledge of cGMP, regulatory expectations, EHS standards, and manufacturing quality systems.
• Proven ability to lead major facility or process start-up efforts from design transfer through operational readiness.
• Experience in sterile injectables, biologics, API, or oral solid dose manufacturing (preferred).
• PMP, Lean, Six Sigma, or equivalent leadership certification preferred.