CQV Process Engineer | GMP Validation & Compliance

Prochem Engineering; Leinster; On-site; EUR 70,000 - 90,000; 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 within the capital projects group, ensuring CQV strategies meet GMP, regulatory expectations, and company standards. The role requires applying risk-based thinking to CQV scope, reviewing qualification plans, and guiding project teams and vendors to deliver compliant,

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related).
• 5+ years of commissioning/qualification experience.
• Strong GMP/ICH knowledge and CQV principles.
• Experience reviewing CQV documentation and lifecycle artifacts.

Responsibilities

• Provide technical oversight to CQV activities in line with GMP and regulatory expectations.
• Review and approve CQV strategies, plans, and lifecycle documentation.
• Guide project teams and CQV service providers to ensure regulatory alignment.
• Ensure qualification activities stay in control and inspection-ready.

Skills

CQV experience

GMP knowledge

Risk-based thinking

Stakeholder management

Analytical skills

Communication skills

Education

Bachelors degree in Engineering (Chemical, Mechanical, Electrical or related)

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 within the capital projects group, ensuring CQV strategies meet GMP, regulatory expectations, and company standards. The role requires applying risk-based thinking to CQV scope, reviewing qualification plans, and guiding project teams and vendors to deliver compliant,