Upstream CQV Lead

EFOR; Limerick; On-site; EUR 90,000 - 140,000; Full time

Job summary

EFOR is seeking an Upstream CQV Lead to oversee commissioning, qualification, and validation of upstream bioreactor, media preparation, and cell culture equipment. The role ensures compliance with GMP and smooth delivery to operations.

The candidate will lead CQV activities, develop qualification strategies, and manage FAT/SAT/site acceptance with vendors, coordinating with process engineers, automation, and QA to ensure robust CQV execution.

Qualifications

• Minimum a bachelor’s degree in science, engineering or equivalent field.
• 7+ years of CQV experience in biopharmaceutical manufacturing with emphasis on upstream processes.
• Experience with cell culture, fermentation, and upstream technology platforms.
• Knowledge of EU GMP / FDA regulatory standards for bioprocess systems.
• Strong project management, stakeholder engagement and technical writing abilities.

Responsibilities

• Lead CQV efforts for upstream equipment and processes (bioreactors, fermentation, media prep).
• Develop and execute qualification strategies and protocols for upstream systems.
• Oversee FAT, SAT, and site acceptance testing with vendors and stakeholders.
• Coordinate with process engineers, automation, and QA on URS, design, and risk assessments.
• Drive resolution of CQV deviations and changes for upstream systems.
• Support cross-functional meetings and status reporting on CQV progress.
• Provide technical guidance on bioprocess commissioning and validation requirements.

Skills

CQV experience

Upstream bioprocess

Regulatory compliance

Technical writing

Stakeholder management

Education

Bachelor’s degree in science/engineering

Job description

The Upstream CQV Lead is responsible for commissioning, qualification, and validation of upstream operations, including bioreactors, media preparation, and cell culture equipment. This role ensures robust compliance with GMP and smooth delivery to operations.

Key Responsibilities:

• Lead CQV efforts for upstream equipment and processes (bioreactors, fermentation, media prep).
• Develop and execute qualification strategy and protocols for upstream systems.
• Oversee FAT, SAT, and site acceptance testing with vendors and project stakeholders.
• Coordinate with process engineers, automation, and QA on URS, design, and risk assessments.
• Drive resolution of CQV deviations and changes for upstream systems.
• Support cross-functional meetings and status reporting on CQV progress.
• Provide technical guidance to the team on bioprocess commissioning and validation requirements.

Requirements:

• Bachelor’s degree in science, engineering, or similar field.
• At least 7 years’ CQV experience in biopharmaceutical manufacturing, with strong upstream process focus.
• Familiarity with cell culture, fermentation, and upstream technology platforms.
• Knowledge of regulatory standards (EU GMP, FDA) for bioprocess systems.
• Strong project management, stakeholder engagement, and technical writing skills.