Job Description
A CQV Engineer is required by CareerWise Recruitment for our multinational pharmaceutical client in Dublin for a full time onsite, initial 12-month contract role, to start in the new year.
The CQV Engineer will lead CQV work for a number of projects including bulk processing, fill/pack lines and utilities/facilities upgrades.
Role of this position
1. Develop and execute commissioning, qualification, and validation protocols for equipment, utilities, and processes.
2. Prepare detailed documentation including URS, FRS, IOQ, and PQ protocols.
3. Coordinate and perform risk assessments and impact assessments for new and existing systems.
4. Collaborate with cross-functional teams to ensure timely project delivery.
5. Troubleshoot and resolve issues that arise during the CQV process.
6. Ensure compliance with cGMP, FDA, and other relevant regulations and guidelines.
7. Maintain accurate and up-to-date documentation and reports.
8. Provide training and guidance to operational staff on validated systems and procedures.
JOB REQUIREMENTS
9. Bachelor's Degree (L8) in Engineering/Science/Technical.
10. Minimum of 5+ years relevant professional experience within the pharmaceutical industry.
11. Experience in process, fill/pack and utility systems of interest.