QC Engineer (Micro)

QC engineer (micro)

Tasks:

• Method validation BacTalert method for EFA unprocessed bulk:
• reporting + inspection readiness FDA or other external inspections
• method evaluation for cleaning samples -> define strategy/business case, validation requirements + set-up studies
• Recombinant Factor C (rFC) test method implementation on water samples as alternative for LAL testing. (reduction of animal related reagents for LAL testing)
• Participate in global working group on the roll-out of rFC versus rCr(recombinant cascade reagents) for product testing: define strategy + validation requirements
• Implementation of outsourced micro identification approach on the existing Maldi-TOF analyzer: goal: increase of micro identification levels with maldi – decommissioning identification with micro-seq(qPCR techno)
• Digitization of micro method validations (bioburden/endotox): set-up of data structure to allow reporting out of lims. (goal: quicker validation turn around times)
• Launch products: Low Endotoxin Recovery evaluation: implementation of required method changes to reduce the risk on low endotox recovery for new launch products
• Supports operational team in the complex micro investigations
• Screening new techno for automated plate counting on EM samples as well as on product samples (membrane filtration): business case evaluation together with global QC excellence team.

The different tasks are always performed in a cross functional internal team (QC micro ops, QA, validation, IT) and the strategic projects are in collaboration with the global QC excellence team with representatives of several other QC labs from EU/US/Canada.

Competencies:

• Master in micro or biochemistry, at least 5 years experience
• Experience in GMP method validation or alternative micro methods is recommended
• Micro scientific knowledge required based on education or though experience
• Strong in analytical thinking, teamwork, agile working,…
• Experience with external compliance audits is a plus
• Strong communication skills in writing and verbal