CQV Engineer (OSD)

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 is an engineering consultancy company specialising in project management, talent solutions, and commissioning, qualification and validation (CQV) services. We partner with many of the world's largest life sciences and technology companies, supporting the delivery of their most strategic and technically complex projects.

CQV Engineer

We are seeking an experienced CQV Engineer to support large-scale capital projects within a highly regulated pharmaceutical manufacturing environment.

The successful candidate will be responsible for commissioning and qualification activities associated with Oral Solid Dosage (OSD) manufacturing equipment, facilities and utilities. Working closely with Engineering, Validation, Quality and Operations teams, the CQV Engineer will support equipment installation, testing, qualification and handover, ensuring compliance with cGMP requirements and project timelines.

Key Responsibilities

• Commissioning & Qualification: Plan, coordinate and execute CQV activities for OSD manufacturing equipment, including granulation, blending, compression/tableting, coating and associated process systems.
• Protocol Development & Execution: Prepare, review and execute commissioning and qualification documentation, including FAT, SAT, IQ and OQ protocols, test scripts and final reports.
• Technical Documentation: Review User Requirement Specifications (URS), Functional and Design Specifications, P&IDs, equipment drawings and vendor documentation to ensure alignment with project and regulatory requirements.
• Equipment & Systems Qualification: Support qualification of manufacturing equipment, facilities, utilities and associated automation systems from installation through to operational handover.
• Project Delivery: Collaborate with Project Engineering, Validation and Operations teams to ensure CQV milestones are achieved in accordance with project schedules.
• Vendor & Contractor Coordination: Liaise with equipment suppliers, contractors and third-party service providers during FAT/SAT, installation, commissioning and qualification activities.
• Deviation & Risk Management: Identify, document and resolve commissioning and qualification deviations, support risk assessments and ensure appropriate corrective actions are implemented.
• Compliance & Safety: Ensure CQV activities comply with site procedures, global cGMP standards, EHS requirements and applicable regulatory guidelines.
• System Handover: Compile and review qualification packages, turnover documentation and supporting technical records to facilitate successful handover to Manufacturing and Operations.

Required Qualifications & Experience

• Degree in Engineering (Mechanical, Chemical, Process or related discipline) or a relevant technical qualification.
• Previous experience in a CQV, Validation or Project Engineering role within the pharmaceutical or life sciences sector.
• Experience commissioning and qualifying pharmaceutical manufacturing equipment and associated process systems.
• Knowledge of FAT, SAT, IQ and OQ activities, including protocol preparation, execution and reporting.
• Experience working within a highly regulated cGMP manufacturing environment.
• Ability to interpret engineering drawings, P&IDs, technical specifications and equipment documentation.
• Strong technical problem-solving, documentation and organisational skills.
• Excellent communication and stakeholder management skills, with the ability to work effectively across multidisciplinary project teams.
• Familiarity with risk-based qualification approaches, GAMP 5, ASTM E2500 and relevant regulatory guidance.
• Experience with process utilities, HVAC, cleanroom systems and manufacturing automation.