CQV Engineer – Sligo | Cregg Group

Cregg Group is partnering with a thriving biologics and pharmaceutical company in Sligo to hire a CQV Engineer for an exciting contract opportunity. This role offers excellent career progression opportunities within a dynamic pharmaceutical environment focused on continuous improvement and GMP compliance.

About the Role

We are seeking an experienced CQV Engineer to lead commissioning, qualification, and validation activities for facility utilities and process equipment. This position involves comprehensive planning, execution, and reporting of CQV activities while ensuring adherence to cGMP standards and regulatory requirements.

Key Responsibilities

• Prepare, execute, and report on CQV activities including C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ, and PQ activities
• Prepare, review, and approve project documentation ensuring technical accuracy and cGMP compliance
• Support design reviews and system risk assessments collaborating with multiple stakeholders
• Verify vendor documentation executions comply with GxP practices and support CQV requirements
• Complete field verifications during static and dynamic functional testing procedures
• Participate in startup activities of energized equipment and coordinate with vendors for project planning
• Perform system P&ID walkdowns with construction teams prior to handover and track punch list completion
• Facilitate mechanical completion processes in conjunction with construction teams and contractors
• Provide regular project status updates and risk assessments to key stakeholders
• Support seamless handover of contractor and vendor systems to end users
• Assist in investigations of process equipment anomalies, utility system issues, and safety incidents

Required Qualifications

Essential Requirements

• Minimum 4 years of experience in biotechnology or pharmaceutical industry in CQV or similar role
• Proven track record in authoring, reviewing, and executing CQV activities for facility, utility, and process equipment
• Strong understanding of regulatory and industry standards for GMP and GDP
• Excellent technical writing skills including deviation reports and validation documentation
• Demonstrated ability to manage multiple tasks, troubleshoot complex issues, and maintain attention to detail

Preferred Qualifications

• Experience with clean utilities and aseptic processing facilities
• Computer Systems Validation (CSV) background
• Temperature mapping experience for temperature control devices and sterilization cycles
• Commissioning qualification experience in project environments
• Experience attending Factory Acceptance Tests (FATs) at vendor sites in mainland Europe

What We Offer

• Competitive contract rates commensurate with experience
• Opportunity to work with cutting-edge biologics and pharmaceutical technologies
• Professional development and career progression opportunities
• Collaborative team environment with industry-leading professionals
• Exposure to state-of-the-art pharmaceutical manufacturing facilities

Ready to Apply?

Join our client’s dynamic team and advance your career in pharmaceutical commissioning, qualification, and validation. This contract position offers excellent exposure to industry best practices and cutting-edge biotechnology processes.

APPLY NOW