Senior Manager, GE CQ AMER

Lonza; Bend (OR); Hybrid; Confidential; Full time

Job summary

Lonza in Bend, Oregon seeks a Senior Manager, GE CQV AMER to lead CQV activities for CAPEX projects in life sciences manufacturing. This role collaborates with project directors, engineering and Quality to ensure regulatory compliance and on-time delivery. Office-first with 20% remote work and up to 30% travel.

You will lead a CQV team, develop strategies and plans, and drive continuous improvement across CQV activities while aligning with Lonza's standards.

Qualifications

• Significant experience in pharmaceutical or GMP environments with CQV/validation leadership.
• Experience leading CQV activities for spray drying equipment/processes.
• Proven ability to manage resources, budgets, schedules, and risk in complex CAPEX programs.

Responsibilities

• Lead CQV activities across CAPEX projects ensuring regulatory compliance and quality standards.
• Manage and develop CQV engineers and technicians with resource planning.
• Develop CQV strategies, project plans, and quality plans aligned with standards.
• Oversee schedules, budgets, risk, and escalate issues to maintain delivery timelines.
• Collaborate with Project Directors, Engineering, Quality, Operations, Procurement, and suppliers.
• Provide SME leadership and drive CQV best practices and training.

Skills

CQV leadership

Project management

Cross-functional leadership

Risk management

Analytical thinking

Regulatory compliance

Education

Bachelor’s degree in Engineering

Job description

Senior Manager, GE CQV AMER

Location: Bend, Oregon (with support for projects across the Americas).

Join Lonza's Global Engineering team and play a critical role in delivering complex CAPEX projects that support the manufacture of life-changing therapies. As Senior Manager, GE CQV Bend, you will lead commissioning, qualification, and validation (CQV) activities across a portfolio of investments, ensuring regulatory compliance, operational excellence, and successful project delivery.

This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).

Travel up to 30% is required.

What you will get:

A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Lead commissioning, qualification, and validation (CQV) activities across a portfolio of CAPEX projects, ensuring compliance with regulatory requirements, quality standards, and project objectives.
• Manage and develop a team of CQV engineers and technicians, ensuring appropriate resource allocation, capability development, and successful project execution.
• Develop and implement CQV strategies, Project Execution Plans, and Project Quality Plans aligned with global engineering and quality standards.
• Oversee project schedules, budgets, and resource forecasts, proactively identifying risks, resolving issues, and escalating concerns when necessary to maintain project delivery timelines.
• Collaborate closely with Project Directors, Project Managers, Engineering, Quality, Operations, Procurement, and external suppliers to ensure seamless integration of CQV activities.
• Serve as the subject matter expert (SME) for commissioning, qualification, and validation, providing technical leadership and guidance across multiple complex initiatives.
• Drive continuous improvement by delivering CQV training, implementing best practices, and optimizing processes to enhance project performance and compliance.

What we are looking for:

• Bachelor’s degree in Engineering, Life Sciences, or another relevant scientific or technical discipline.
• Significant experience in pharmaceutical, biotechnology, engineering, or GMP-regulated manufacturing environments, including leadership responsibility for CQV, validation, engineering, or project execution activities.
• Experience supporting or leading CQV activities for spray drying equipment and processes within pharmaceutical, biotechnology, chemical, or related GMP-regulated manufacturing environments.
• Demonstrated experience managing project resources, budgets, schedules, and risk assessments within complex CAPEX programs.
• Proven ability to lead and influence cross-functional and global teams within a matrix organization.
• Strong analytical, problem-solving, and decision‑making capabilities, with the ability to interpret complex data and drive actionable outcomes.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.