Process Validation Engineer

Responsibilities

• You manage and provide support to several compounding and filling projects (development and/or validation) within the sterile production department,
• API source changes
• Projects related to new ANNEX 1 requirements
• Realize small to medium optimization and implementation projects that are individually assigned
• You coordinate end-to-end project activities (i.e. planning, preparation, execution, implementation, service support)
• You write and execute protocols for the planned studies
• You witness development and validation studies
• You follow-up the sampling & testing plan with production and laboratories
• You evaluate study data results and write reports for the executed studies
• Execute process changes to APIs, excipients, primary packaging, and product contact materials and manage component specifications and qualifications of primary packaging components and product contact materials
• Assist the quality and production department in handling deviations, and executing the investigations and activities for problem solving and corrective and preventive actions
• Assist the Pharmaceutical Technical Operations (PTO) department in compliance driven activities such as the continued process verification program and annual product review
• Report into the PTO lead

Requirements

• Master in scientific degree
• Relevant experience in pharmaceutical Formulation & Filling processes
• Knowledge of sterile drug product manufacturing technologies
• The ability to work on a project base and within team of technical experts
• Advanced knowledge of English (talking/writing/reading)
• Technical writing skills
• Problem solving skills
• Analytical mindset and project-minded
• Process and data driven
• Flexible/Committed
• Autonomous
• Team player/Collaborative
• On-the-floor approach