As a Project Engineer Formulation you will be responsible of the coordination of validation and planning activities in capital projects, including scheduling and managing project plans.
Interpretation and application of GMP regulations (US, EU, ?), international standards (ISO, ICH), and Quality StandardsCoordinating verification/validation activities, drafting and reviewing validation documents, and acting as a primary contact for Engineering and Quality Assurance regarding validation and change controlFacilitating Quality Risk Assessments and serving expertise in verification/validation/QRMManaging one or more products or projects, addressing urgent quality investigations, conducting risk assessments, implementing changes, and introducing new productsFor laboratory contexts, you will be responsible for qualification and validation of method improvements, developing computer-controlled systems, and providing backup for other project engineers
Qualifications:
Possess a master's degree in civil, industrial, bio-engineering, industrial pharmacy, or equivalent by experience, or a scientific field (Bio engineer, Pharmacist, Biochemistry, Biotechnology)Experience in production environments, pharmaceutical industry, aseptic processes, cleaning, disinfection, and sterilization are advantageousStrong communication, stakeholder management, organizational skills, accuracy, and technical writing abilities are essentialProficiency in Dutch and English is required