Lead CQV Engineer for Biopharma Equipment & Validation

LSC, Life Science Consultants; Munster; On-site; EUR 90,000 - 120,000; Full time

Job summary

LSC Life Science Consultants in Ireland seeks a Lead C&Q Engineer to drive full-cycle Commissioning and Qualification for critical biopharma processing equipment, from FAT/SAT through site handover, working with multidisciplinary teams.

The role calls for extensive CQV leadership in aseptic fill-finish lines, lyophilizers, CIP/SIP, and regulatory alignment with FDA/EMA, EU Annex 1, and data integrity. Prior contract experience and strong vendor management are essential.

Qualifications

• Experience leading CQV projects in biopharma or GMP settings.
• Aseptic processing, lyophilization, CIP/SIP, and isolator tech knowledge.
• Familiarity with GMP standards (FDA/EMA), EU Annex 1, ASTM E2500, data integrity.

Responsibilities

• Lead CQV lifecycle for core process equipment, from FAT/SAT to site handover.
• Author and review validation docs (URS, FAT/SAT reports, IQ/OQ/PQ).
• Own process system CQV packages (aseptic lines, lyophilizers, vessels, CIP/SIP).
• Manage vendor engagement and coordinate FAT/SAT activities.
• Implement risk-based validation strategies and drive CAPA actions.
• Collaborate with Process Engineering, Automation, QA, Operations, and Projects.

Skills

CQV leadership

biopharma GMP experience

aseptic processing

CIP/SIP

FDA/EMA regulatory knowledge

vendor management

technical writing

Education

Bachelor's or Master's in Chemical/Process Engineering or related

Job description

LSC Life Science Consultants in Ireland seeks a Lead C&Q Engineer to drive full-cycle Commissioning and Qualification for critical biopharma processing equipment, from FAT/SAT through site handover, working with multidisciplinary teams.

The role calls for extensive CQV leadership in aseptic fill-finish lines, lyophilizers, CIP/SIP, and regulatory alignment with FDA/EMA, EU Annex 1, and data integrity. Prior contract experience and strong vendor management are essential.