Job Title: CQV Engineer (Commissioning, Qualification & Validation)
Company: Metron Engineering
Location: County Kerry, Ireland
Contract Type: 6-Month Contract (Potential Extension up to 2 years)
Experience: 4–8 Years
Rate: €60/hour
Travel: May be for future assignments across the UK and Europe as required.
About the Role
Metron Engineering is seeking an experienced CQV Engineer to support commissioning and qualification activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will play a key role in delivering CQV activities across Clean Utilities, Upstream Process (USP), and Downstream Process (DSP) equipment within GMP-regulated environments.
This is an excellent opportunity to work on high-profile life sciences projects while gaining exposure to future assignments across the UK and Europe.
Key Responsibilities
- Execute commissioning and qualification activities for GMP process equipment and utility systems.
- Develop, review, and execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Perform commissioning and qualification of:
- Clean Utilities (Purified Water, Water for Injection, Clean Steam, Clean Compressed Air, Process Gases, etc.)
- USP equipment including bioreactors, media preparation systems, seed trains, and associated process equipment.
- DSP equipment including chromatography skids, filtration systems, ultrafiltration/diafiltration (UF/DF), buffer preparation systems, and process vessels.
- Support system walkdowns, punch list management, and mechanical completion activities.
- Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and system start-up activities.
- Review vendor documentation, technical drawings, P&IDs, equipment manuals, and turnover packages.
- Perform risk assessments and ensure qualification activities align with project requirements.
- Coordinate with Engineering, Operations, Quality Assurance, Validation, Automation, and project teams.
- Support deviation investigations, change controls, and CAPA activities related to CQV.
- Ensure all activities comply with GMP, GDP, and company quality procedures.
- Prepare summary reports and final qualification documentation.
- Support project milestones while maintaining high standards of safety and compliance.
Required Experience
- 4–8 years of CQV experience within the pharmaceutical or biotechnology industry.
- Strong experience commissioning and qualifying Clean Utility systems, USP and DSP process equipment.
- Hands-on experience executing IQ, OQ, and PQ protocols.
- Experience supporting commissioning, start-up, and system turnover activities.
- Ability to interpret engineering drawings, P&IDs, and technical documentation.
- Experience working in GMP-regulated manufacturing environments.
- Familiarity with validation lifecycle principles and risk-based qualification methodologies.
- Strong troubleshooting and problem-solving skills.
- Excellent technical writing and documentation abilities.
Preferred Qualifications
- Bachelor's degree in Mechanical, Chemical, Process, Electrical, Pharmaceutical Engineering, or a related engineering discipline.
- Experience on large-scale pharmaceutical or biotechnology capital projects.
- Knowledge of ISPE GAMP, ASTM, and current GMP guidelines.
- Experience working with multidisciplinary project teams in fast-paced environments.
Key Competencies
- Strong communication and interpersonal skills.
- Ability to work independently and collaboratively within cross-functional teams.
- Excellent organisational and time management skills.
- Detail-oriented with a commitment to quality and compliance.
- Proactive approach to solving technical challenges.
- Flexible and willing to travel as project requirements evolve.
Location
This role is based in County Kerry, Ireland, with onsite project support required.
Future project assignments may involve travel within Ireland, the United Kingdom, and Europe, depending on client and business needs.
Contract Details
- Contract Duration: 6 Months
- Hourly Rate: €60/hour
- Start Date: Immediate / As Soon As Available
- Work Arrangement: Onsite
Why Join Metron Engineering?
At Metron Engineering, you'll have the opportunity to contribute to cutting-edge pharmaceutical and biotechnology projects while working alongside experienced industry professionals. We foster a collaborative environment that values technical excellence, continuous learning, and career development. As our project portfolio continues to grow across Ireland, the UK, and Europe, successful consultants will have opportunities to support a diverse range of high-value CQV assignments.
Pay: £50.00-£55.00 per hour
Work Location: In person
