Downstream CQV Lead

EFOR; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

EFOR in Ireland seeks a Downstream CQV Lead to manage commissioning, qualification, and validation of downstream processing systems, including chromatography and filtration. You will drive compliance and ensure operational readiness on site.

You will lead CQV activities, develop IQ/OQ/PQ protocols, manage vendor testing, and coordinate with engineering, process, and QA teams. Mentor CQV staff and ensure systems meet regulatory and project requirements.

Qualifications

• 7+ years CQV experience in downstream bioprocessing equipment.
• Expertise in chromatography, filtration, and downstream technologies in pharma/biotech.
• Strong knowledge of regulatory guidelines and validation standards.
• Excellent communication and leadership abilities.

Responsibilities

• Lead implementation of CQV activities for downstream equipment and processes.
• Develop, review, and approve qualification protocols (IQ/OQ/PQ) for chromatography, filtration, and related systems.
• Manage vendor relationships and support installation and testing activities.
• Drive risk assessment, change control, and deviation resolution.
• Coordinate with engineering, process, and QA teams for seamless CQV delivery.
• Mentor and train CQV staff in downstream process qualification best practices.
• Ensure downstream systems meet regulatory and project requirements.

Skills

CQV leadership

Regulatory compliance

Project coordination

Vendor management

Communication skills

Problem solving

Education

Engineering/Chemistry/Life sciences degree

Tools

Qualification protocols (IQ/OQ/PQ)

Chromatography systems

Filtration systems

Job description

The Downstream CQV Lead manages the commissioning, qualification, and validation of downstream processing systems, including chromatography, filtration, and buffer prep for the site. The role enforces compliance and drives operational readiness.

Key Responsibilities:

• Lead implementation of CQV activities for downstream equipment and processes.
• Develop, review, and approve qualification protocols (IQ/OQ/PQ) for chromatography, filtration, and related systems.
• Manage vendor relationships and support installation and testing activities.
• Drive risk assessment, change control, and deviation resolution.
• Coordinate with engineering, process, and QA teams for seamless CQV delivery.
• Mentor and train CQV staff in downstream process qualification best practices.
• Ensure downstream systems meet regulatory and project requirements.

Requirements:

• Degree in engineering, chemistry, or life sciences.
• Minimum 7 years’ CQV experience, specifically with downstream bioprocessing equipment.
• Expertise in chromatography, filtration, and downstream technologies in pharma/biotech.
• Good understanding of relevant regulatory guidelines and validation standards.
• Strong communication, leadership, and problem-solving abilities.