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.

The Opportunity

You will 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. Your leadership will ensure that each project achieves target functionality, regulatory compliance, and operational excellence while fostering a collaborative, high-performing team environment. Key accountabilities include:

You will 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
You will 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
You will 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
You will 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
You will 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
You will 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
You will 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

Who You Are

You hold a Bachelor's degree in Engineering, Quantity Surveying, or related field with 8+ years (6 plus Masters) of experience in capital project management, Commissioning, Qualification, and Validation within pharmaceutical or biopharmaceutical sterile drug product manufacturing environments, with 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) combined with in-depth understanding of manufacturing operations, end-user needs, and the ability to advocate for operational requirements while ensuring all compliance obligations are met
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

The expected salary range for this position based on the primary location of Oregon is $109,000 - $204,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

This is an on-site position; no remote options are available at this time.

Relocation benefits are available for this posting.

#LI-PK1

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

About the company

Genentech is a biotechnology company focused on researching and developing medicines and therapies to address unmet medical needs. It uses large-scale R&D, with about 13,500 employees and 40 approved medicines; it develops biologics and other therapies marketed through healthcare providers, generating revenue from sales. It differentiates itself with a large patent portfolio (around 20,000 patents) and multiple FDA Breakthrough Therapy Designations, along with a patient-centric approach that weighs access and affordability. Its goal is to advance medical science and deliver high-quality, effective therapies that improve patient health and support the broader medical community.

Company Size

10,001+

Company Stage

Grant

Total Funding

$47.8M

Headquarters

San Francisco, California

Founded

1976

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Simplify's Take

What believers are saying

Hillsboro broke ground September 28, 2026 on a $750 million device fill-finish plant.
The project adds 250 jobs and strengthens U.S. supply for oncology, neurology, immunology.
Roche opened Boston's CVRM Innovation Center on September 17, 2026, expanding discovery capacity.

What critics are saying

September 2026 layoffs cut 265 South San Francisco jobs, ending a 40-year plant.
June and July 2026 cuts removed 103 gRED roles, signaling continuing research retrenchment.
Vabysmo concentration leaves Genentech vulnerable to a retinal franchise reversal by 2027.

What makes Genentech unique

Roche-backed Genentech pairs drug discovery with manufacturing, diagnostics, and global commercialization at scale.
Vabysmo delivered real-world eye-disease data on September 30, 2026 across 28 countries.
The September 24, 2026 Earendil deal shows Genentech still commands elite biotech partners.

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Benefits

Performance Bonus
Relocation Assistance

Growth & Insights and Company News

Headcount

6 month growth

1 year growth

-3%

2 year growth

-3%

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FDA approves Tecentriq for stage III colon cancer, cutting recurrence risk by 50%

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Genentech

Principal Commissioning and Qualification Manager

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