CQV Engineer – Pharma Equipment Qualification

GerTEK Project Management and Technical Services; Athlone; On-site; EUR 65,000 - 80,000; Full time

Job summary

GerTEK Project Management and Technical Services in Ireland seeks an experienced CQV Engineer to support large-scale capital projects in a regulated pharmaceutical manufacturing environment.

You will be responsible for commissioning and qualification activities for OSD manufacturing equipment, facilities and utilities, coordinating with Engineering, Validation, Quality and Operations to meet cGMP standards and project timelines.

Qualifications

• Degree in Engineering or related technical qualification.
• Experience in CQV/Validation or Project Engineering in pharma or life sciences.
• Experience commissioning and qualifying pharma manufacturing equipment and process systems.
• Knowledge of FAT, SAT, IQ and OQ activities with protocol preparation and execution.

Responsibilities

• Plan, coordinate and execute CQV activities for OSD equipment including granulation, blending, compression/tableting, coating.
• Prepare, review and execute commissioning and qualification documentation (FAT, SAT, IQ, OQ).
• Review URS, FDS, P&IDs, equipment drawings and vendor docs for alignment with requirements.
• Support qualification of equipment, facilities, utilities and automation systems from installation to handover.
• Collaborate with Project Engineering, Validation and Operations to meet CQV milestones.
• Liaise with equipment suppliers, contractors and third-party providers during FAT/SAT and installation.
• Identify, document and resolve deviations; support risk assessments and CAPAs.
• Ensure CQV activities comply with site procedures, cGMP standards and regulatory guidelines.
• Compile and review qualification packages and turnover docs for handover to Manufacturing.

Skills

CQV Engineering

Regulatory compliance

Process validation

GAMP 5 knowledge

Technical documentation

Cross-functional collaboration

Problem solving

Education

Engineering degree (Mechanical/Chemical/Process)

Job description

GerTEK Project Management and Technical Services in Ireland seeks an experienced CQV Engineer to support large-scale capital projects in a regulated pharmaceutical manufacturing environment.

You will be responsible for commissioning and qualification activities for OSD manufacturing equipment, facilities and utilities, coordinating with Engineering, Validation, Quality and Operations to meet cGMP standards and project timelines.