Senior CQV Engineer

We have an opening for a Senior CQV Engineer

This person will be responsible for a variety of validation engineering related activities and for resolving project issues following cGMP regulations and Client standards. Leadership is an essential part of this role. The ability to motivate and mentor others in a dynamic, growing office environment is required.

Proven CQV leadership excellence experience in complex (life sciences/biopharma/pharmaceutical) facilities is required. 

Who we are

PM Group is an employee owned, international project delivery firm with a team of 3,600+ people.  We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations.  We are focused on growing a sustainable business centered on our people, our clients and trade partners.

• Serve as the Validation Engineering representative and technical SME on cross-functional teams, including facilities, utilities, and equipment.

• Develop and implement validation strategies; coordinate validation activities for small to large-scale client projects involving equipment, utilities, and facilities.

• Lead CQV (Commissioning, Qualification, and Validation) efforts for large pharmaceutical projects throughout all phases—Basic Design, Detailed Design, Construction, and CQV—covering systems such as cell culture, purification, filling, media formulation and dispensing, isolators, vial and cryo-bag filling machines.

• Manage validation deliverables to ensure new facilities, utilities, and equipment are completed on schedule and within budget; proactively escalate potential issues as needed.

• Author, review, approve, and oversee validation lifecycle documentation, including Validation Plans, URS, Qualification Protocols, and Reports.

• Execute qualification and validation protocols where required.

• Participate in validation-related activities such as design, build, maintenance, and change control processes.

• Lead and contribute to risk assessments for new and existing equipment and facilities.

• Monitor project progress, manage schedules, evaluate risks, and communicate status updates and recommendations to stakeholders.

• Collaborate effectively with cross-functional teams to achieve technical and project goals.

• Mentor and support junior engineers if needed.

• Bachelor's degree in Engineering or Science required; Master's degree in Engineering or Science preferred.

• Minimum of 7 years of experience in CQV (Commissioning, Qualification, and Validation), with successful completion of at least three major capital projects.

• Extensive experience in cross-functional and interdisciplinary project coordination, ideally within the biopharmaceutical sector.

• Proven track record of operating as a CQV Team Lead on large-scale pharmaceutical projects.

• Strong leadership and time management skills; capable of working independently and making sound decisions.

• Flexible and willing to travel locally to support project needs.

• Skilled in scoping work, preparing project proposals, and developing cost estimates.

• Confident in delivering presentations to clients, students, and academic audiences on CQV-related topics.

• Deep understanding of CQV execution methodologies for GMP pharmaceutical facilities.

• Ability to engage constructively with senior management to advocate for project CQV scope, resources, and priorities.

• Committed to maintaining and advancing quality standards within the department.

• Excellent communication, client engagement, and people management skills.

• Strong knowledge of relevant technical standards and regulatory requirements.

All of your information will be kept confidential according to EEO guidelines.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know. 

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