Senior Upstream CQV Lead: Bioprocess Commissioning

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

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.