CQV Quality Engineering Lead

i-Pharm GxP; Illinois; On-site; USD 150,000 - 190,000; Full time

Job summary

i-Pharm GxP seeks 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 to ensure CQV excellence and regulatory readiness.

Qualifications

• 15+ years in pharmaceutical or biotechnology manufacturing.
• Degree in Engineering or relevant science 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.

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.

Skills

Quality oversight

CQV Engineering

Regulatory compliance

Cross-functional leadership

Education

Engineering degree

Job description

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 within CQV Engineering Quality, QA Engineering, Validation Quality, Global Engineering Quality or Capital Project Quality would be highly relevant.