Our partner is looking for a Lab Operations Project Engineer to join its team. This international company is well known for its pharmaceuticals.
Lab Operations Project Engineering entails being responsible for the compliance assessment of method validation and compendial compliance dossiers. This service involves the careful implementation of new test methods and procedures in Quality Control Operations, including coordinating and planning project activities.
Laboratory Operations Project Engineer
Job description
- Implementation of new test methods and procedures in Quality Control Operations
- Coordination and planning of project activities
- Writing and reviewing protocols, testing scripts, and reports
- Management of deviations
- Review of validation and transfer test results
- Validation of necessary files (e.g., SoftMaxPro, Excel)
- Verification of compendial tests
- Support of QC analysts during test execution
- Troubleshooting for issues encountered during testing
- Performing root cause analysis using methods such as DMAIC
- Co-authoring submissions for new medicines/vaccines
- Efficient and thorough investigation of analytical deviations
- Determination of root causes and initiation of corrective and preventive actions to address quality-related deficiencies
- Execution of strategic initiatives
- Resolution of complex issues
- Development of innovative solutions
- Guidance of technical direction
- Coordination of other resources and facilitation of knowledge transfer within service parameters
Profile
- Master’s degree is commonly required, typically in industrial, civil, or bio-engineering, or industrial pharmacy, or a scientific field such as biochemistry or biotechnology
- Perfect command of Dutch and good knowledge of English (written and oral) is required
- Strong communication skills (written and oral)
- Strong organizational skills and accuracy
- Strong technical writing ability
- Analytical skills and problem-solving abilities
- Experience in a GMP environment is required
- Team player with strong interpersonal skills
Offer
- Company car