PROJECT INGENIEUR freelance

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 Standards
• Coordinating verification/validation activities, drafting and reviewing validation documents, and acting as a primary contact for Engineering and Quality Assurance regarding validation and change control
• Facilitating Quality Risk Assessments and serving expertise in verification/validation/QRM
• Managing one or more products or projects, addressing urgent quality investigations, conducting risk assessments, implementing changes, and introducing new products
• For 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 advantageous
• Strong communication, stakeholder management, organizational skills, accuracy, and technical writing abilities are essential
• Proficiency in Dutch and English is required