AS CPV Engineer will play a crucial role in ensuring the stability and efficiency of our production processes. You will be responsible for overseeing GMP compliance, quality assurance, and reporting, while focusing on Continuous Process Verification, trending and improvements deriving thereof. This is a hands-on role that requires a proactive problem-solver with a background in engineering, particularly within the pharmaceutical or life sciences industry.
Key Responsibilities:
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.
Required Skills and Qualifications:
- 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 We 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.
Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.