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.