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CQV Area Lead

  • Location: Tipperary, E91 V091
  • Salary: €80 - €90 per hour
  • Job Type:Contract

Posted 4 days ago

  • Sector: Life Sciences , Pharmaceuticals
  • Contact: Luke Charlson
  • Contact Email: luke.charlson@nrl.co.uk
  • Contact Phone: +441524865555
  • Start Date: 07 September 2025
  • Expiry Date: 08 October 2025
  • Job Ref: V-294283

We are seeking an experienced CQV Area Lead to oversee commissioning and qualification activities for API (Active Pharmaceutical Ingredient) equipment at the MSD Ballydine site. This is a full-time contract position for an initial duration of 12 months.

The successful candidate will lead a team of CQV Engineers throughout the project lifecycle, ensuring alignment with GMP standards and project objectives.

Key Responsibilities:

  • Lead and manage a team of CQV Engineers across all project phases.

  • Develop and implement Validation Master Plans, Commissioning Master Plans, and project-specific procedures.

  • Author, review, and approve SATs, IQs, and OQs for API equipment.

  • Drive the Design Review (DR) process and conduct GMP Risk Assessments (FMEA).

  • Define and execute the appropriate Commissioning and Qualification strategy for API systems.

  • Review technical documentation from early design stages to ensure GMP and CQV compliance.

  • Investigate and resolve technical issues in collaboration with engineering teams and equipment vendors.

  • Ensure project execution adheres to company guidelines, departmental procedures, and safety standards.

  • Participate in Mechanical Completion activities including walkdowns, punch list management, and system acceptance.

  • Prepare and monitor CQV schedules and progress reports.

  • Coordinate daily activities of CQV Engineers and ensure timely delivery of tasks.

  • Apply project management principles to coordinate CQV activities and reporting.

  • Manage and coordinate contractors and vendors during commissioning and qualification phases.

  • Prepare and deliver Final Handover Reports to client stakeholders.

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Required Qualifications & Experience:

  • Bachelor’s degree in Engineering, Life Sciences, or related field.

  • Significant experience in CQV roles within the pharmaceutical or biotech industry.

  • Proven experience with API equipment and related systems.

  • Strong knowledge of GMP, validation lifecycle, and regulatory requirements.

  • Proficiency in writing and reviewing CQV documentation.

  • Experience with project management tools and methodologies.

  • Excellent communication, leadership, and stakeholder management skills.

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Desirable Skills:

  • Familiarity with automation systems and data integrity principles.

  • Ability to work in a fast-paced, multi-disciplinary project environment.




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