CQV Lead

Athlone
3 weeks ago
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Team Horizon is seeking a CQV Lead for a leading pharmaceutical company in Athlone.

We are seeking an experienced Senior CQV Lead to oversee the development and execution of a comprehensive CQV plan for a major upgrade to the manufacturing facility. This CQV lead will be pivotal in ensuring that all systems, equipment, and processes meet regulatory compliance, operational readiness, and project timelines. The Lead CQV Engineer reports to the Engineering Director/Capital Project Lead and is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition and C&Q activities at site.

Why you should apply:

  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

  • You enjoy working on exciting projects and want to work with a global manufacturing site in Athlone.

  • You are a project engineer seeking a new challenge and have experience working on a range of projects from the installation of new machinery to the co-ordination of contractors and vendors

    What you will be doing:

  • Lead the CQV strategy for the facility upgrades, ensuring alignment with project goals and regulatory requirements.

  • Develop and maintain the CQV master plan, protocols, and schedules.

  • Coordinate cross-functional teams including engineering, quality, manufacturing, IT, automation and project management.

  • Manage commissioning and qualification activities for utilities, equipment, and process systems.

  • Ensure timely execution of IQ/OQ/PQ protocols and documentation.

  • Drive resolution of CQV issues, deviations, and change controls.

  • Ensure adherence to GMP, FDA, EMA, and other applicable regulatory standards.

  • Maintain accurate and audit-ready CQV documentation.

  • Support regulatory inspections and internal audits.

  • Act as the primary CQV point of contact for project stakeholders.

  • Provide regular updates on CQV progress, risks, and mitigation strategies.

  • Collaborate with vendors and contractors to ensure CQV deliverables are met.

  • Any other duties as assigned.

    What you need to apply:

  • Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biopharmaceutical, or related field).

  • Minimum 5 years of experience in C&Q within the Life Sciences industry.

  • Strong knowledge of regulatory guidelines (FDA, EMA, ISPE, GAMP).

  • Hands-on experience with risk-based qualification and C&Q protocols.

  • Strong problem-solving, communication, and teamwork skills. Experience working on large-scale capital projects is a plus

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