Commissioning Manager

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

The Role:

The Commissioning, Qualification, and Validation (CQV) Manager is responsible for overseeing and managing the CQV activities for the company's facilities, equipment, utilities, and processes. They ensure that all CQV activities are performed on schedule, in budget and in compliance with relevant regulatory requirements, industry standards, and company policies. The CQV Manager collaborates with cross-functional teams to ensure successful commissioning, qualification, and validation of systems to support manufacturing operations.

Key Responsibilities:

• Plan and execute according to the project schedule the commissioning, qualification, and validation activities for new and existing facilities, equipment, utilities, and processes.
• Develop and implement the overall CQV strategy and roadmap for the organization.
• Establish & evolve CQV policies, procedures, and guidelines in alignment with regulatory requirements and industry best practices.
• Lead and manage directly / indirectly a team of CQV professionals, providing guidance, direction, leadership, ownership and support.
• Support development and review of CQV protocols, reports, and documentation to ensure compliance and accuracy.
• Collaborate with cross-functional teams, including Engineering, Quality Assurance, Manufacturing, and Regulatory Affairs, to identify CQV requirements and coordinate activities.
• Conduct risk assessments and ensure appropriate mitigation strategies are implemented.
• Manage relationships with external vendors, consultants, and contractors involved in CQV activities.
• Stay current with industry trends, regulatory updates, and best practices related to CQV.
• Provide guidance and support during regulatory inspections and audits.

Who You Are

• Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree advantageous.
• You have proven professional experience delivering capital projects with significant CQV experience.
• Thorough knowledge of regulatory requirements and industry standards related to CQV, such as FDA regulations and cGMP guidelines.
• Demonstrated experience in managing CQV projects, including planning, resource allocation, and budgeting.
• Strong leadership skills with the ability to effectively communicate and collaborate with cross-functional teams.
• Experience with risk-based approaches to CQV.
• Excellent problem-solving and analytical skills.
• Professional certifications related to CQV (e.g., ASQ CQE, ISPE) are desirable.
• Excellent communication skills. Experience in distilling from complex to simple executive storyboards.
• Desirable - Experience in process plant construction and construction safety, and equipment installation

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!