Senior CQV Engineer - Denmark, Copenhagen - 12 Months Initial Contract Our global engineering client specialise in delivering innovative solutions for the pharmaceutical and life sciences industries. Their focus is on designing and optimising advanced facilities that enable the development and production of critical medicines. With a strong commitment to quality, sustainability, and cutting-edge technology, they help clients bring life-changing treatments to patients worldwide. They are currently looking for a Senior CQV Engineer to join their team in Copenhagen.What you'll do:
Coordinate Mechanical Completions Line Walks, ensuring readiness for commissioning.Oversee the development and execution of IQ/OQ/PQ protocols, ensuring compliance with GMP and regulatory standards (FDA, EMA, MHRA).Facilitate daily board meetings, providing clear updates on progress, risks, and mitigation strategies.Collaborate with cross-functional teams (Engineering, QA, Operations) to ensure seamless system integration.Manage project documentation, including qualification reports, deviation logs, and risk assessments.
What you'll need:
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical) or Life Sciences.Advanced degrees or certifications (e.g., PMP, Lean Six Sigma) are a plus.Extensive experience in commissioning and qualification, preferably in biopharma or regulated industries.Proven experience in leading large-scale projects, including planning, execution, and delivery.Strong understanding of commissioning of Clean & Black utilities.Familiarity with GMP, GEP, FDA, and EU regulations.
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