Pharma CQV Process Equipment Engineer

DPS Group Global; Leinster; In loco; EUR 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

DPS Group Global is seeking an experienced Process Equipment Engineer to support major capital projects on site, providing technical oversight of CQV activities throughout the project lifecycle.

The role emphasizes pharmaceutical manufacturing processes, CQV principles and GMP compliance, with URS development and design experience to ensure compliant solutions and qualification strategies, from concept through handover.

Competenze

• Minimum 5 years' CQV experience in a regulated pharmaceutical environment.
• URS development and review to meet operational and compliance requirements.
• Strong understanding of GMP regulations and industry standards (EU GMP, FDA, ICH).
• Experience authoring, reviewing and approving URS and CQV lifecycle documents.
• Demonstrated ability to lead design reviews and qualification activities.

Mansioni

• Provide technical oversight and review of CQV documentation and qualification plans.
• Develop, review and challenge URS to ensure project deliverables meet requirements.
• Translate process requirements into GMP-compliant design and qualification strategies.
• Support equipment and process design activities across concept to handover.
• Identify CQAs and CPPs; justify and control them throughout CQV.
• Apply risk-based methods to define scope and testing.
• Review and approve CQV strategies, plans and lifecycle documents.
• Lead project teams, vendors and CQV service providers for regulatory compliance.
• Support change controls, deviations and investigations from a compliance perspective.
• Ensure systems remain validated and inspection-ready.
• Provide technical leadership during project execution.

Conoscenze

CQV experience

URS development

GMP compliance

Regulatory awareness

Stakeholder management

Communication

Problem solving

Qualification strategies

CQV lifecycle documentation

Formazione

Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related discipline)

Strumenti

ASTM E2500

ISPE Baseline Guides

Descrizione del lavoro

DPS Group Global is seeking an experienced Process Equipment Engineer to support major capital projects on site, providing technical oversight of CQV activities throughout the project lifecycle.

The role emphasizes pharmaceutical manufacturing processes, CQV principles and GMP compliance, with URS development and design experience to ensure compliant solutions and qualification strategies, from concept through handover.