Senior Manager, GE CQ AMER
Lonza
Summary
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.
Job description
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 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.
Requirements
- 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.
Benefits
- Performance-related bonus
- Medical, Dental & Vision
- 401(k) Matching
- Life Insurance
- Short-term Disability
- Long-term Disability
- Employee Assistance Programs
- Paid Time Off
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.