CQV Engineer

Our global engineering partner is recognised for delivering advanced, future‑focused solutions to the pharmaceutical and life sciences sectors. Their expertise lies in designing and optimising state‑of‑the‑art facilities that support the development and manufacture of essential medicines. With a strong emphasis on quality, sustainability, and technological innovation, they enable clients to bring transformative therapies to patients around the world.

They are now seeking a Senior CQV Engineer to join their team in Copenhagen.

Role Responsibilities:

• Lead and coordinate Mechanical Completion Line Walks, ensuring systems are fully prepared for commissioning activities.

• Oversee the creation and execution of IQ/OQ/PQ protocols, maintaining strict alignment with GMP and global regulatory requirements (FDA, EMA, MHRA).

• Drive daily board meetings, delivering clear updates on progress, risks, and mitigation actions.

• Work collaboratively with Engineering, QA, and Operations teams to ensure smooth and compliant system integration.

• Maintain and control all project documentation, including qualification reports, deviation records, and risk assessments.

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical) or Life Sciences.

• Additional certifications (PMP, Lean Six Sigma, etc.) are advantageous.

• Significant experience in commissioning and qualification, ideally within biopharma or other regulated environments.

• Demonstrated ability to lead large-scale project delivery, from planning through execution.

• Strong technical understanding of Clean and Black utility commissioning.

• Solid knowledge of GMP, GEP, FDA, and EU regulatory frameworks.