QC Qualification Engineer (Laboratory Analytical Computerised Systems)

A global biopharamceutical company is preparing for an upcoming project and is looking for a QC Qualification Engineer to join its Quality Control team on a 12-month contract starting January 2027. You will own the qualification lifecycle of laboratory analytical computerised systems, working closely with F&E, QA, QC and IT.

Key Responsibilities

• Support change control initiation and take end-to-end ownership of change controls for laboratory analytical computerised system qualification
• Draft and execute validation documents: Validation Plan and Requirements, IOQ/PQ test scripts, summary reports and Data Integrity Risk Assessments
• Draft system decommissioning documents (decommissioning plan and summary report)
• Draft Operations and Maintenance SOPs
• Support the generation of the Preventive Maintenance program for the system
• Coordinate with equipment vendors on vendor qualification activities
• Work with F&E, QA, QC and IT stakeholders to keep activities on schedule

Requirements

• Bachelor’s degree in Science, Engineering or a related field
• Hands-on experience in laboratory equipment qualification
• Working knowledge of lab instruments, computerised system validation and controlled temperature chamber qualification
• Strong understanding of validation approaches, strategies and philosophies
• Experience with change control methodology
• Good knowledge of data integrity, GMP and GDP
• Experience in a biotech or pharmaceutical environment preferred
• Experience with KNEAT or other electronic validation tools preferred
• Familiarity with any of the following is a bonus: Charles River endotoxin readers, Agilent Epoch 2 microplate readers, Beckman Coulter acoustic liquid handlers
• Good interpersonal and communication skills, and a collaborative team player
• Strong focus on safety, quality and timelines
• Able to work independently with minimal supervision