We are seeking a talented Process Engineer to join a leading life sciences organization in Leiden, Netherlands. This role focuses on Downstream Processing (DSP) and Technology Transfers, ensuring production processes are efficiently transferred, optimized, and continuously improved. You will work closely with operations and management to drive process decisions, implement best practices, and support regulatory compliance. Strong communication skills are essential for collaboration with both internal teams and external partners.
Key Responsibilities
- Lead Downstream Processing (DSP) activities, optimizing purification and separation processes.
- Manage technology transfers, ensuring smooth scale-up and transfer of processes between sites or production systems.
- Supervise and continuously assess processes to ensure compliance with validated and regulatory standards.
- Collect, analyze, and report process data to drive continuous improvement.
- Initiate and implement process improvements to enhance safety, quality, reliability, cost, and scheduling.
- Conduct process observations (e.g., Gemba walks) and collaborate with teams to implement sustainable improvements.
- Support change control, risk assessments, and product impact evaluations related to DSP and tech transfer activities.
- Participate in continuous process verification (CPV) and other initiatives to ensure process consistency and compliance.
Qualifications
- Relevant university degree or equivalent experience, with at least 3 years of experience in biopharmaceutical process engineering, DSP and tech transfers.
- Language requirements: Dutch A2 and English C1.
- Proficiency in MS Office, data analysis, and business applications.
- Strong analytical thinking, problem-solving skills, and the ability to handle complex processes.
- Self-motivated, proactive, and able to work independently as well as collaboratively.
- Adaptable, stress-resilient, and able to handle changing priorities.