About the company
This international pharmaceutical company, located in the Oss region, is committed to delivering innovative therapies that improve patient health. With a strong focus on quality and operational excellence, the organization continuously invests in modernizing its manufacturing processes. Employees are empowered to make a real impact by driving continuous improvement and supporting critical production systems.
Role description
As a Process Engineer, you will spearhead the transition from manual to automated cleaning systems for pharmaceutical components. This role demands strong expertise in change control, equipment qualification, and cleaning validation. You’ll collaborate closely with Quality Assurance and engineering teams to ensure all project deliverables comply with GMP guidelines and regulatory standards.
Key responsibilities
- Lead the implementation of automated cleaning processes for pharmaceutical components, replacing manual methods
- Prepare and execute change controls, protocols, and reports in alignment with QA approval requirements
- Oversee and contribute to equipment qualification and cleaning validation efforts
- Guide and engage in cross-functional investigations, addressing deviations and CAPAs
- Apply Lean Six Sigma tools to identify and execute process optimization opportunities
- Champion continuous improvement initiatives, leveraging data-driven insights
- Organize and lead kaizen events while mentoring stakeholders on operational excellence best practices
Requirements
- Over 5 years of experience as a Process Engineer in the pharmaceutical sector
- Demonstrated expertise in change control, equipment qualification, and cleaning validation
- Excellent written and verbal communication skills in Dutch (required)
- Capable of working independently and leading cross-functional initiatives
- Familiarity with Lean Six Sigma methodologies and Change Management is a strong advantage
- Confident operating in a GMP-compliant environment
55053
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.