Job Description
A top pharmaceutical company in Dublin is seeking a skilled CQV Engineer to join their team on an initial 16-month contract. The ideal candidate will have a minimum of a BS qualification in a scientific, technical or engineering discipline, along with at least 5 years of experience within the pharmaceutical industry, particularly with utility systems commissioning.
Your Role
1. Develop and execute CQV testing documentation for equipment in the Sterile Drug product facility.
2. Ensure key project deliverables are met for safety, CQV schedule and quality of project-related documentation/electronic records for assigned equipment.
3. Guarantee GMP equipment is tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
4. Verify non-GMP equipment is tested in compliance with project-related standards from a commissioning perspective.
5. Manage deviations associated with assigned equipment and utilities.
6. Risk Management – Identify and categorize CQV risks according to their impact on commissioning and qualification. Generate action plans to mitigate qualification risks.
7. Execute FAT testing and leverage results into the overall qualification process for assigned equipment, facilities and utilities.
8. Ensure all assigned training is executed on time to meet site metrics.
Qualifications:
1. Demonstrable capacity to effectively execute the CQV testing approach assigned from initiation to completion.
2. CQV project lifecycle experience from design through to C&Q and handover.
3. Demonstrable experience of performing as part of a diverse team of CQV professionals/contractors to deliver on tasks safely, with quality focus, on time and within budget.
4. Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment and Utilities with integrated automation platforms.
5. Specific experience with the CQV preparation and execution for black utility systems, including compressed air plant steam, process waste, chilled water.
6. Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on-time performance.
7. Excellent communication skills and the ability to influence others.
8. Demonstratable experience working in teams in a matrix environment to deliver CQV elements.