Principal Commissioning and Qualification Manager

Roche•Hillsboro, OR

5h•$109,000 - $204,000•Onsite

About The Position

This role is a vital part of Roche's Global Engineering team, which partners with Pharma Technical Operations (PT) and other divisions to deliver world-class capital projects that enable our global manufacturing operations. As a Commissioning & Qualification Manager, you will lead complex, cross-functional teams through the critical C&Q phase of project delivery, ensuring compliant, on-time, and on-budget execution while maintaining the highest standards of quality and safety. You will collaborate closely with project management teams, manufacturing operations, quality partners, site leadership, and external service providers to translate regulatory requirements and operational needs into innovative, practical solutions. This position offers the opportunity to make a direct impact on Roche's ability to manufacture life-changing medicines by ensuring our facilities and systems are rigorously validated and ready to support GMP operations globally.

Requirements

Bachelor's degree in Engineering, Quantity Surveying, or related field.
8+ years (6 plus Masters) of experience in capital project management, Commissioning, Qualification, and Validation within pharmaceutical or biopharmaceutical sterile drug product manufacturing environments.
Demonstrated expertise in GMP facilities, utilities, automation systems, and packaging operations.
Proven leadership of cross-functional, matrixed teams with excellent collaboration, communication, and team-building skills.
Ability to influence and partner effectively with internal stakeholders (manufacturing, quality, site operations, project management) and external service providers across culturally diverse, multi-level organizational environments.
Strong project management acumen including proficiency in advanced planning tools, risk-based methodologies, work breakdown structures, resourcing, estimating, and schedule development.
Demonstrated track record of delivering complex projects on time and within budget.
Deep pharmaceutical regulatory knowledge and compliance expertise (FDA, EMA, ICH).
In-depth understanding of manufacturing operations, end-user needs, and the ability to advocate for operational requirements while ensuring all compliance obligations are met.
Fluent in German and English (written and spoken).
Cultural agility and the courage to drive change while balancing risk, innovation, and pacing for sustainable success.
Proactive relationship-building skills with customers, stakeholders, and team members at all organizational levels.

Responsibilities

Serve as Sub-Project Manager for Commissioning & Qualification Engineering, leading cross-functional teams through all phases of C&Q delivery while maintaining accountability for scope, budget, schedule, and compliance with Roche's quality and engineering standards.
Lead and build engaged cross-functional C&Q project teams by setting clear expectations, motivating team members, facilitating strong communication, and making decisive decisions that drive alignment and accountability across disciplines.
Develop and execute comprehensive C&Q strategies aligned with risk-based approaches (ASTM E2500), including scope definition, detailed work breakdown structures, resource planning, realistic scheduling, and cost estimating for mid to large-sized capital projects.
Drive stakeholder alignment and maintain close coordination with project management, manufacturing operations, quality partners, site leadership, and external contractors to ensure integrated execution and early identification of risks and deviations.
Manage the full C&Q project lifecycle—from options analysis and planning through detailed execution, contractor oversight, safety program deployment, training coordination, and handover—ensuring compliance with Roche PQS, Engineering Manual, and all applicable regulations.
Proactively monitor project performance against plan, provide regular status updates on progress, resource demand, schedule changes, and risks, and lead corrective actions to maintain on-time, on-budget delivery.
Onboard, mentor, and manage C&Q team members and external contractors with clear technical guidance, performance monitoring, and accountability for contractual obligations and behavioral expectations.
Champion innovation and best practices in C&Q project management methodologies, challenging the status quo constructively to identify more effective ways of working and communicating improvements across the project team and broader organization.