As a Qualification Engineer you will be responsible of the qualification of analytical methods, drafting protocols, coordinate lab work with the lab analist team, analyzing results and drafting reports. Potentially this service requires collaborating with other departments in Belgium or elsewhere to facilitate the qualification or root cause investigations related to the qualification. If required, the service will also include the selection, purchase and qualification of new lab equipment, this includes coordinating with vendors, procurement and lab teams to facilitate the purchase, qualification and operation of the equipment.
The service involves facilitating Risk Assessments and serving expertise in verification/validation. Furthermore, services extend to managing one or more projects, addressing urgent quality investigations, conducting risk assessments, implementing changes, and introducing new methods/equipment. For laboratory contexts, the service is being responsible for qualification and validation of method improvements, developing computer-controlled systems, and providing backup for other project engineers.
Services might involve the interpretation and application of GMP regulations (US, EU,...), international standards (ISO, ICH), and Quality Standards (PQS).
Qualifications:
* Master's degree in industrial, bio-engineering, industrial pharmacy, or equivalent by experience, or a scientific field (Bio engineer, Pharmacist, Biochemistry, Biotechnology)
* Experience in pharmaceutical (GMP) lab operations environment, production environments, or pharmaceutical industry in general are advantageous
* Hands on experience with method validation, validation strategies and statistical data analysis is highly valuable
* Strong communication, stakeholder management, organizational skills, accuracy, and technical writing abilities are essential
* Proficiency in Dutch and English is required