Senior CQV Engineer - GMP Compliance & Validation Leader

Next Phase Recruitment; Leiria; On-site; EUR 60,000 - 90,000; Full time

Job summary

Our client, a world-renowned CDMO, is seeking a senior CQV engineer to lead commissioning and qualification activities across engineering projects, ensuring GMP compliance and readiness for regulatory inspections.

You will develop CQV standards and SOPs, review designs for regulatory alignment, mentor engineers, and coordinate between engineering, QA and operations in a global manufacturing setting. Fluency in English and cross-functional collaboration are required.

Qualifications

• Degree in Engineering or related scientific field (mandatory).
• 5+ years in CQV including design, implementation and qualification.
• Strong knowledge of GMP, GAMP and compliance regulations.
• Experience managing audits/regulatory inspections.

Responsibilities

• Lead CQV activities and serve as reference for compliance standards.
• Develop and maintain CQV standards, SOPs, and technical guidelines.
• Review designs for regulatory and internal compliance.
• Lead CQV scope across design, commissioning and qualification.
• Mentor engineers in regulatory and technical best practices.
• Coordinate between engineering, QA, validation, operations and IT.
• Drive commissioning and qualification execution to ensure GMP compliance.

Skills

CQV methodologies

Regulatory compliance

Audits & inspections

Cross-functional communication

Process verification

Education

Engineering (Chemical, Mechanical, Electrical, Automation)

Tools

MS Office

CAD tools

Digital design tools

Job description

Our client, a world-renowned CDMO, is seeking a senior CQV engineer to lead commissioning and qualification activities across engineering projects, ensuring GMP compliance and readiness for regulatory inspections.

You will develop CQV standards and SOPs, review designs for regulatory alignment, mentor engineers, and coordinate between engineering, QA and operations in a global manufacturing setting. Fluency in English and cross-functional collaboration are required.