CQV Process Engineer: Validation & Compliance Lead

Prochem Engineering; Leinster; On-site; EUR 80,000 - 120,000; Full time

Job summary

Prochem Engineering is seeking an experienced CQV Process Engineer for a state-of-the-art pharmaceutical site in Co. Kildare.

You will provide technical oversight for commissioning, qualification, and validation activities across capital projects, ensuring GMP compliance and inspection readiness. You will guide CQV strategies, review lifecycle documentation, and apply risk-based thinking to define CQV scope and execution, collaborating with delivery teams and vendors to maintain validated

Qualifications

• Bachelor's degree in Engineering or related field with strong CQV exposure.
• Minimum 5+ years in commissioning/qualification within pharma.
• Solid GMP knowledge and regulatory awareness (EU FDA ICH).
• Ability to apply risk-based thinking to CQV scope and tests.
• Strong analysis, attention to detail and problem solving.

Responsibilities

• Provide oversight and technical review of CQV documentation and protocols.
• Ensure CQV activities align with GMP expectations and company standards.
• Evaluate process understanding, CQAs and CPPs in design and qualification.
• Apply risk-based thinking to qualification scope, test coverage, and verification.
• Challenge project teams and CQV providers to meet best practices and regulations.
• Monitor CQV execution for adherence to procedures and resolution of deviations.
• Review change controls and provide input to design and project reviews.

Skills

CQV lifecycle understanding

Risk-based thinking

GMP knowledge

Analytical / problem-solving

Stakeholder management

Education

Bachelor's degree in Engineering

Validation/CQV certification (preferred)

Job description

Prochem Engineering is seeking an experienced CQV Process Engineer for a state-of-the-art pharmaceutical site in Co. Kildare.

You will provide technical oversight for commissioning, qualification, and validation activities across capital projects, ensuring GMP compliance and inspection readiness. You will guide CQV strategies, review lifecycle documentation, and apply risk-based thinking to define CQV scope and execution, collaborating with delivery teams and vendors to maintain validated