Requirements: English
Company: Prothya Biosolutions
Region: Amsterdam , North Holland
Purpose of the Position: As a Continuous Improvement Engineer, you will play a crucial role in ensuring the stability and efficiency of our production processes. You will oversee GMP compliance, quality assurance, and reporting, with a focus on process design, qualification, validation, and continuous process verification. This hands-on role requires a proactive problem-solver with a background in engineering, particularly within the pharmaceutical or life sciences industry. Key Responsibilities: GMP Compliance Quality Assurance Ensure all continuous improvement initiatives align with Good Manufacturing Practices (GMP) to uphold product quality and regulatory compliance. Conduct regular assessments and audits of production processes to identify improvement areas and verify compliance. Process Design Optimization Design and optimize production processes, with a focus on the filling line, to enhance efficiency, consistency, and quality. Integrate best practices and innovative solutions to reduce operational disruptions and improve process flow. Qualification Validation Activities Plan, execute, and document the qualification and validation of equipment, systems, and processes to meet regulatory standards and predefined specifications. Continuous Process Verification (CPV) Implement and maintain CPV strategies to monitor processes in real-time, ensuring ongoing compliance and product quality. Product Quality Impact Assessment Conduct detailed assessments to evaluate the impact of changes or deviations on product quality, ensuring all corrective actions are accurately identified and addressed. Product Quality Review Lead periodic reviews of product quality, analyze performance data, identify trends, and recommend actionable improvements to maintain high standards. Regulatory Documentation Reporting Prepare and submit detailed reports to regulatory authorities, ensuring accuracy, completeness, and compliance with relevant guidelines. Continuous Improvement Initiatives Identify and drive initiatives to optimize processes, reduce costs, and enhance overall quality, fostering a culture of continuous improvement within the team. Required Skills and Qualifications: Educational Background: Bachelors degree in Engineering or a related field, preferably with experience in pharmaceutical manufacturing. Professional Experience: Minimum of 3 years in a continuous improvement or production engineering role, with a strong focus on GMP compliance, quality assurance, and regulatory reporting. Technical Skills: Proficiency in qualification, validation, and CPV methodologies. Strong analytical abilities and experience in troubleshooting within dynamic production environments. Personal Traits: A proactive and resilient individual who thrives in a fast-paced, sometimes unpredictable environment. Adaptable to shifting priorities and capable of balancing short-term problem-solving with long-term process improvements. Language Skills: English (C1 level) and Dutch (B1 level). Our Offer: A full-time position with a competitive salary. A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly. Flexible working hours, in consultation. Personal training budget of 2,100 every 3 years. Contribution to travel expenses from the first kilometer. Good accessibility by public transport, with private parking available. Pension scheme with Zorg Welzijn.