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CPV Engineer
Prothya Biosolutions Netherlands B.V.
What you'll do
Continuous Process Verification (CPV)
Implement and maintain CPV strategies to monitor processes in real-time, ensuring ongoing compliance and product quality.
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 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.
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.
What you'll bring
Educational Background: Bachelor’s degree in Engineering or a related field, preferably with experience in pharmaceutical manufacturing.
Professional Experience: Minimum of 3 years in a MSAT, continuous improvement or production engineering role, with a strong focus on Continuous Process Verification, 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.
Must have a strong experience in trending, data analysis and statistics.
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.
Professional level in English. Additional Dutch is preferred.
What's on offer
Full-time employment with flexible working hours in consultation (working part-time can be discussed)
A salary between € 4.702,26 and € 6.759,41 gross per month (based on full-time employment)
A budget of 16,66% (holiday allowance and 13th month) on top of your gross salary, yours to spend or to save monthly
30 holiday days (based on fte)
A personal training budget of €2,100 every three years to foster professional growth and development.
Contribution to travel expenses from the first kilometer.
Excellent accessibility by public transport and private parking available.
A pension plan with Zorg & Welzijn, providing security for your future.
A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.