Principal Commissioning and Qualification Manager

About the role

This role sits within Roche's Global Engineering team, which partners with Pharma Technical Operations and other divisions to deliver capital projects supporting global manufacturing. As Sub-Project Manager for Commissioning and Qualification Engineering, you lead cross-functional teams through the C&Q phase, keeping scope, budget, schedule and compliance on track so that facilities and systems are validated and ready for GMP operations.

Key responsibilities

• Lead and build engaged cross-functional C&Q project teams, setting clear expectations and driving alignment across disciplines
• Develop and run C&Q strategies using risk-based approaches (ASTM E2500), including scope, work breakdown structures, resource planning, scheduling and cost estimating for mid to large capital projects
• Coordinate with project management, manufacturing operations, quality partners, site leadership and external contractors, and flag risks and deviations early
• Manage the full C&Q lifecycle, from options analysis and planning through contractor oversight, safety programs, training and handover, in line with Roche PQS, the Engineering Manual and applicable regulations
• Monitor performance against plan, report progress, resources, schedule changes and risks, and lead corrective actions
• Onboard, mentor and manage team members and contractors, holding them accountable for contractual obligations and behaviour
• Promote innovation in C&Q project management methods and share improvements across the team and organisation

Required profile

• Bachelor's degree in Engineering, Quantity Surveying or a related field
• 8+ years of experience (6+ with a Master's) in capital project management, commissioning, qualification and validation in pharmaceutical or biopharmaceutical sterile drug manufacturing, with GMP facilities, utilities, automation and packaging expertise
• Proven leadership of cross-functional, matrixed teams and strong stakeholder influence
• Strong project management acumen and a track record of delivering complex projects on time and within budget
• Deep knowledge of FDA, EMA and ICH regulations and manufacturing operations

Required skills

• Advanced planning tools, risk-based methodologies, work breakdown structures, resourcing, estimating and schedule development
• Commissioning, qualification and validation (C&Q)

What we offer

• Expected salary range of $109,000 - $204,000 for the Oregon location, depending on experience and qualifications
• A discretionary annual bonus may be available
• Relocation benefits are available
• The position is on-site; no remote options are available