Junior CQV Engineer (Utilities)

Ascend Project Management; South Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

AscendPM is partnering with a leading life sciences company in South Dublin to recruit a Junior CQV Engineer on a 12-month contract. The role supports equipment, capital projects and clean utilities across the validation lifecycle, with emphasis on sterile fill-finish environments.

The successful candidate will lead CQV activities, develop qualification strategies, coordinate activities across multidisciplinary teams, and ensure compliance with GMP and regulatory standards throughout project

Qualifications

• Minimum 6 years of experience in Commissioning, Qualification & Validation within pharmaceutical/biotech sectors.
• Experience managing CQV activities across capital projects and equipment lifecycles.
• Strong understanding of GMP and regulatory requirements.

Responsibilities

• Lead and provide technical CQV support across the full validation lifecycle, from design to qualification and ongoing validation maintenance.
• Develop and execute risk-based qualification strategies for equipment and clean utilities (URSs, V&V plans, FATs, SATs, IOQs, PQs).
• Coordinate qualification activities to keep systems validated and compliant throughout their lifecycle.
• Support sterile manufacturing systems qualification including vial/syringe filling and clean utilities.
• Collaborate with Engineering, Manufacturing, Quality and external vendors to align with Quality by Design principles.

Skills

CQV

Validation

GMP

Regulatory

Quality

Sterile manufacturing

Education

Engineering or Science degree

Job description

We are working with a well-known life sciences company based in South Dublin to recruit a Junior Commissioning, Qualification and Validation (CQV) Engineer. This is a 12 month contract.

The CQV Engineer will join a dynamic team supporting a range of capital, equipment and clean utility lifecycle projects.

The successful candidate will ensure CQV activities are completed safely, on schedule, and in full compliance with GMP, regulatory and quality requirements. The role will have a particular focus on equipment validation within a sterile fill-finish manufacturing environment, ensuring systems achieve and maintain the required levels of performance, reliability and compliance.

Key Responsibilities

• Lead and provide technical CQV support across the full validation lifecycle, from design and specification through commissioning, qualification, validation and ongoing validation maintenance.
• Develop and execute risk-based qualification strategies for equipment, automated systems and clean utilities, including URSs, QRAES, Validation Plans, FATs, SATs, IOQs and PQs.
• Coordinate qualification activities and ensure equipment, utilities and manufacturing systems remain in a validated and compliant state throughout their lifecycle.
• Support the qualification and validation of sterile manufacturing systems, including vial and syringe filling, formulation, inspection and clean utility systems.
• Collaborate with Engineering, Manufacturing, Quality, Planning, Product Development and external vendors to ensure Quality by Design principles and validation requirements are incorporated throughout project delivery.
• Support regulatory inspections, change controls, SOP updates and continuous improvement initiatives, ensuring all CQV activities remain aligned with GMP, regulatory requirements and applicable industry standards.

Key Requirements

• Minimum 6 years' experience in Commissioning, Qualification & Validation within the pharmaceutical, biotechnology or related regulated industry.
• Third-level qualification or equivalent in Engineering, Science, Validation or a related technical discipline.
• Proven experience managing CQV activities across pharmaceutical or biotechnology capital projects and equipment lifecycle programmes.
• Strong experience with risk-based commissioning and qualification methodologies, with a detailed understanding of GMP and regulatory requirements.
• Practical experience with sterile manufacturing equipment, particularly filling, formulation, inspection and clean utility systems within a drug product environment.
• Strong technical, organisational and communication skills, with the ability to work effectively across multidisciplinary and multi-site teams and manage multiple projects to schedule.

Due to the high volume of applications, we may not be able to respond to every applicant.

AscendPM do not forward candidate CVs to clients without prior consent.