The Lab Operations Project Engineer entails being responsible for the compliance assessment of method validation and compendial compliance dossiers. It involves the careful implementation of new test methods and procedures in Quality Control Operations, including coordinating and planning project activities.
Your tasks:
* Writing and reviewing protocols, testing scripts, and reports, as well as managing deviations. A key responsibility is to review validation and transfer test results, validate necessary files (e.g., SoftMaxPro, Excel), and verify compendial tests
* Supporting QC analysts during test execution, conducting troubleshooting for issues, performing root cause analysis using methods like DMAIC, and may co-author submissions for new medicines/vaccines
* Efficient and thorough investigating of analytical deviations, determining root causes, and initiating corrective/preventive actions to address quality-related deficiencies
Qualifications:
* 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)
* Strong communication skills (written and oral), organizational skills, accuracy, and strong technical writing ability are essential
* Analytical skills and problem-solving abilities
* Experience in a GMP environment is consistently desired or required
* Being a team player and having strong interpersonal skills are also highly valued traits
* A preference for several years of relevant experience, particularly within a pharmaceutical or production environment