QC Qualification Engineer (Laboratory Analytical Computerised Systems)
Must-have:QA/Test
About the company
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.
Your tasks
- 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