CQV Quality Engineering Lead

We are supporting a global biopharmaceutical organisation seeking an experienced CQV Engineering Quality Lead to provide Quality oversight across commissioning, qualification, validation and engineering activities within a GMP manufacturing environment.

The role will work closely with Engineering, QA, Validation, Operations and external vendors across capital projects and manufacturing lifecycle activities.

Key Responsibilities

• Provide Quality oversight of Commissioning, Qualification and Validation activities.
• Review and approve URS, drawings, IQ/OQ/PQ documentation and engineering lifecycle documents.
• Provide Quality oversight across technology transfer, process validation, cleaning validation, filter validation, CPV and APR activities.
• Support method transfer, method validation, stability and leachables & extractables activities.
• Provide Quality oversight of CAPEX/OPEX projects, equipment qualification and vendor qualification.
• Support projects from Phase III through commercial manufacturing.
• Provide QA SME support for deviations, change controls and regulatory inspections.
• Review and approve engineering, validation and Quality documentation.
• Partner with Engineering, QA Operations, Sterility Assurance, Regulatory and R&D teams.
• Support development of global Quality and Engineering standards, SOPs and procedures.

Experience Required

• 15+ years' experience within pharmaceutical or biotechnology manufacturing.
• Degree in Engineering or a relevant scientific discipline.
• Strong experience providing Quality oversight of CQV and Engineering activities.
• Experience with equipment qualification, commissioning, validation and technology transfer.
• Experience supporting GMP capital projects.
• Strong understanding of GMP and global regulatory requirements.
• Biologics manufacturing experience preferred.
• Strong stakeholder management and cross-functional leadership experience.

Ideal Background

Experience with in CQV Engineering Quality, QA Engineering, Validation Quality, Global Engineering Quality or Capital Project Quality would be highly relevant.