CQV Process Engineer - GMP Validation & CQV Oversight

DPS Group Global; Leinster; On-site; EUR 70,000 - 110,000; Full time

Job summary

DPS Group Global is seeking a Process Engineer to support capital projects on site, providing technical oversight of CQV activities and ensuring GMP principles are applied throughout project delivery.

The successful candidate will have a Bachelor's degree in Engineering and at least 5 years' CQV experience in a regulated pharma setting, with strong CQAs/CPPs, risk assessment skills and ability to liaise with stakeholders to maintain inspection readiness, aligned to EU GMP, FDA and ICH guidelines.

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related) required.
• Minimum 5 years' CQV experience in a regulated pharmaceutical environment.
• Strong understanding of CQAs and CPPs.
• Experience with EU GMP, FDA and ICH guidelines.
• Proven ability to review CQV lifecycle documentation and manage risk.

Responsibilities

• Provide technical oversight and review CQV documentation.
• Translate process requirements into GMP-compliant design and qualification strategies.
• Support CQV scope, testing and verification activities.
• Review and approve CQV strategies, plans and lifecycle documentation.
• Guide project teams and CQV service providers to ensure compliance.
• Ensure systems remain validated and inspection ready.

Skills

CQV oversight

GMP compliance

CQAs & CPPs

Risk assessment

Documentation review

Stakeholder management

Regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

DPS Group Global is seeking a Process Engineer to support capital projects on site, providing technical oversight of CQV activities and ensuring GMP principles are applied throughout project delivery.

The successful candidate will have a Bachelor's degree in Engineering and at least 5 years' CQV experience in a regulated pharma setting, with strong CQAs/CPPs, risk assessment skills and ability to liaise with stakeholders to maintain inspection readiness, aligned to EU GMP, FDA and ICH guidelines.