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The Continuous Improvement 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 process design, qualification, validation, and continuous process verification. 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:
1. 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.
2. 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.
3. Qualification & Validation Activities
- Plan, execute, and document the qualification and validation of equipment, systems, and processes to meet regulatory standards and predefined specifications.
4. Continuous Process Verification (CPV)
- Implement and maintain CPV strategies to monitor processes in real-time, ensuring ongoing compliance and product quality.
5. 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.
6. Product Quality Review
- Lead periodic reviews of product quality, analyze performance data, identify trends, and recommend actionable improvements to maintain high standards.
7. Regulatory Documentation & Reporting
- Prepare and submit detailed reports to regulatory authorities, ensuring accuracy, completeness, and compliance with relevant guidelines.
8. 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 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.
- Proffesional level Dutch & English language skill
What We Offer:
- Employment Type: Full-time with flexible working hours in consultation.
- Compensation: Salary ranging from €4,379.34 to €6,295.23.
- Additional Benefits:
- 8.33% end-of-year bonus and 8.33% holiday allowance.
- Personal training budget of €2,000 every three years for professional development.
- Travel expense reimbursement starting from the first kilometer.
- Excellent accessibility by public transport, with private parking available.
- 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.
Why Join Prothya Biosolutions?
Working at Prothya means joining a team committed to impactful, hands-on improvement in a high-stakes production environment. If you have a passion for overcoming operational challenges and contributing to enhanced product quality and reliability, this role offers a unique opportunity to make a substantial difference in our manufacturing processes and customer satisfaction.
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.