CQV Engineer

About Your New Employer

• Innovative and Growing Company: Join a dynamic team dedicated to the continuous improvement of pharmaceutical facilities, utilities, and equipment.
• Professional Development: Work in an environment that supports your growth and development, with opportunities to work on both new and legacy equipment.
• Collaborative Culture: Be part of a team that values collaboration and clear communication among all stakeholders.

About Your New Job

• Plan, Execute, and Report: Prepare, execute, and report on CQV activities for assigned systems, including C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ, and applicable PQ activities.
• Documentation and Compliance: Prepare, review, and approve project documentation, ensuring technical accuracy and adherence to cGMP. Confirm all vendor documentation executions are compliant with GxP practices.
• Field Verifications and Startups: Complete field verifications during static and dynamic (functional) tests and participate in startup activities of energized equipment.
• Vendor and Contractor Interaction: Interact with vendors for project planning, perform system P&ID walkdown with construction prior to handover, and manage site attendance for vendors, contractors, and specialist contractors.
• Project Change Management: Manage project change and CQV discrepancies through close interaction with System User and Quality Assurance.

What Skills You Need

• Technical Competence: Strong understanding of GMP/GDP, regulatory and industry standards.
• Communication Skills: Excellent verbal and written communication skills.
• Team Collaboration: Ability to work effectively with Engineering, QA, Operations, Vendors, and Project Managers.
• Attention to Detail: Strong attention to detail is essential.

Essential Education and Experience

• Educational Background: A minimum of an Honors degree in an Engineering or Science discipline.
• Industry Experience: At least 3 years’ experience in the biotechnology and/or pharmaceutical industry, in a CQV role.
• CQV Expertise: Proven experience in authoring, review, and execution of CQV activities on a variety of Facility, Utility, and Process Equipment.

Desired Education and Experience

• Specialized Experience: Experience with clean utilities and aseptic processing facilities would be an advantage.
• Technical Skills: Experience in Computer Systems Validation and temperature mapping of temperature control devices and sterilization cycles is desirable.

What’s on Offer

• Competitive Salary: €55,000 to €65,000
• Benefits: Comprehensive benefits, training, and development opportunities.
• Career Path: Clear career progression and opportunities for growth within the company.

What’s Next

Apply now by clicking the “Apply Now" button or call Ross Keyes on 091749269 for more information. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.