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

Skills

Laboratory Equipment Maintenance and Calibration Management, Computer Systems Validation, Good Documentation Practices, Preventive Maintenance, Quality Control, Risk Assessment, decommission of systems, Technical Writing, SOP Development, Quality Assurance, GMP, validation protocols, Temperature Controlled, Change Control Activities, Vendor Management, Data Integrity, Equipment Qualification, Change Control Procedure, Stakeholder Management, Change Control Management