Compliance & CQV Engineer

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 is a world-renowned CDMO with more than six decades of success supporting the development and manufacture of drug substances, intermediates, and finished products for pharmaceutical partners worldwide. They are celebrated for their advanced process technologies and deep technical expertise across all stages of the product lifecycle. With a diverse, international team and a strong culture of scientific excellence, this company offers an environment where your contributions directly impact global health outcomes while advancing your career in a forward-thinking and inclusive organization.

Responsibilities / Role

In this senior technical position, you will lead CQV activities and serve as a key reference for compliance standards across engineering projects.

• Develop and maintain CQV standards, SOPs, and technical guidelines
• Review project designs for regulatory and internal compliance
• Lead CQV scope across design, commissioning, and qualification phases
• Mentor and coach engineers to ensure technical and regulatory best practices
• Ensure readiness for regulatory inspections and client audits
• Coordinate between engineering, QA, validation, operations, and IT functions
• Drive commissioning and qualification execution to ensure GMP compliance

Qualifications & Experience

• Degree in Engineering (Chemical, Mechanical, Electrical, Automation) or in a related scientific field (mandatory)
• 5+ years of experience in CQV, including system design, implementation, and qualification
• Strong knowledge of GMPs, GAMP, and compliance legislation
• Proven ability to manage or respond to audits and regulatory inspections
• Proficiency in MS Office and CAD tools; experience with digital design tools advantageous
• Fluency in English, both written and verbal

Additional Skills

• Expertise in CQV methodologies, validation principles, and project lifecycle management
• Strong analytical, problem-solving, and cross-functional communication skills
• Hands-on experience with equipment/system testing and process verification
• Solid understanding of engineering documentation such as URS, FDS, and SDS