CQV Engineer

Summary:

Our client is a biopharmaceutical company based in Cork looking for a CQV Specialist to join its team.  The successful candidate will Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.

Responsibilities:

• Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
• Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
• Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
• Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
• Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.
• Support regulatory audits
• Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities
• Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
• Support, lead or guide others in CQV projects.

Qualifications & Experience:

• Degree in a Science or Engineering discipline.
• Minimum 5 years’ experience in a similar role.
• Experience in a GMP environment essential.
• Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory
• Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels