The Company
Our client is a leader in global healthcare with a strong presence in the Netherlands, working on both human and animal health innovations.
About the Role
This role is part of the Filling Production Unit (FPU) and involves overseeing filling and freeze-drying processes for vaccines and pharmaceutical products. The position combines technical expertise, project management, and process optimisation to ensure compliance, efficiency, and continuous improvement within a sterile production environment.
Responsibilities
- Participate in product transfers, optimisations, and troubleshooting across sites and R&D.
- Collect and analyse data for root cause analysis and trend identification.
- Lead or support projects involving equipment adaptation, material changes, and process improvements.
- Draft and maintain SOPs, BMIs, work instructions, and Change Control documentation.
- Serve as backup for Operational Coach, making functional decisions and acting as point of contact.
- Manage validation, calibration, and maintenance activities according to GMP protocols.
- Write User Requirement Specifications (URS) for new equipment and conduct feasibility screenings.
- Maintain production data in SAP and ensure accurate BOM and capacity planning.
- Conduct GMP and SHE inspections and assist during audits.
- Provide training and develop materials to upskill Senior Operators.
- Participate in Tier meetings and continuous improvement initiatives (Kaizen, SPS).
Requirements
- HBO or Vapro C education (e.g., HLO/HTS, microbiology, (bio)chemistry, process technology) or willingness to complete.
- Extensive experience in production environment.
- Strong knowledge of GMP, SHE, and process automation.
- Proficiency in SAP, Trackwise, Hermes, and other production systems.
- Green Belt (Lean Leader) certification preferred.
- Fluent in Dutch and English (spoken and written).
- Familiarity with hazardous substances and GMO legislation.
Other Information
Opportunity to lead projects and contribute to continuous improvement.
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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.