Senior CQV Engineer

Morgan McKinley; Tralee; On-site; EUR 68,000 - 90,000; Full time

Job summary

Morgan McKinley is partnering with a leading global life sciences company in County Kerry to recruit a CQV Engineer for a long-term contract focused on commissioning, validation, and handover of aseptic fill-finish and lyophilization processes. The role requires 3+ years CQV experience in biopharma, strong regulatory knowledge, and excellent technical writing.

You will interact with Construction, Engineering, QA, and Operations to ensure successful FAT/SAT and system handovers on a greenfield

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Chemistry, or a related scientific discipline.
• 3+ years of dedicated CQV engineering experience within the biopharmaceutical or pharmaceutical sector.
• Strong background in aseptic processing, sterile fill-finish, compounding, or lyophilization technologies is highly desirable.
• Familiarity with clean utilities (WFI, Clean Steam, Purified Water) and process cleanroom environments.
• Deep understanding of EU/FDA GMP regulations, Annex 1, data integrity principles, and risk-based validation approaches.
• Excellent technical writing skills, a proactive attitude toward safety and problem-solving, and the ability to adapt to a fast-paced greenfield project environment.

Responsibilities

• Author, review, and execute CQV lifecycle documentation (URS, FMEA, DQ, IQ, OQ, PQ) for clean utilities, process equipment, and automated systems.
• Take technical ownership of assigned systems, ensuring compliance with global regulatory standards (FDA, EMA) and ASTM E2500 principles.
• Partner with design teams and vendors during FAT and SAT.
• Work closely with Construction, Engineering, QA, and Operations teams to ensure seamless system handovers.
• Identify, investigate, and resolve protocol deviations, implementing robust CAPAs.

Skills

Technical writing

Safety mindset

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Biotechnology/Chemistry

Job description

We are partnering with a leading global life sciences company that is currently constructing a €330-million, state-of-the-art biopharmaceutical facility in County Kerry. This cutting-edge, greenfield plant is designed to the highest environmental and sustainability standards and will focus on the aseptic fill-finish and lyophilization manufacturing of advanced biologics (including mAbs and ADCs).

As a CQV Engineer, you will join the project during a critical phase of construction, commissioning, and validation. This is a long-term contract offering the opportunity to work with next-generation biotechnology equipment and play a key role in building a facility from the ground up.

Key Responsibilities

• Execution: Author, review, and execute CQV lifecycle documentation (including URS, FMEA, DQ, IQ, OQ, and PQ protocols) for clean utilities, process equipment, and automated systems.
• System Ownership: Take technical ownership of assigned systems, ensuring compliance with global regulatory standards (FDA, EMA) and ASTM E2500 principles.
• Vendor Management: Partner with design teams and vendors during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Cross-Functional Collaboration: Work closely with Construction, Engineering, Quality Assurance, and Operations teams to ensure seamless system handovers.
• Troubleshooting: Identify, investigate, and resolve protocol deviations, implementing robust corrective and preventive actions (CAPAs).

Requirements & Qualifications

• Education: Bachelor\'s degree in Engineering, Biotechnology, Chemistry, or a related scientific discipline.
• Experience: 3+ years of dedicated CQV engineering experience within the biopharmaceutical or pharmaceutical sector.
• Technical Expertise: Strong background in aseptic processing, sterile fill-finish, compounding, or lyophilization technologies is highly desirable.
• Utility & Equipment Knowledge: Familiarity with clean utilities (WFI, Clean Steam, Purified Water) and process cleanroom environments.
• Regulatory Knowledge: Deep understanding of EU/FDA GMP regulations, Annex 1, data integrity principles, and risk-based validation approaches.
• Soft Skills: Excellent technical writing skills, a proactive attitude toward safety and problem-solving, and the ability to adapt to a fast-paced greenfield project environment.