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

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