Development Operator Liquids & Parenterals Pilot Plant
A pharmaceutical company is committed to improving the lives of millions of patients worldwide. This role offers a unique opportunity to make a real impact in the development of innovative therapies. The Drug Product Research & Development (DPRD) department plays a crucial role in manufacturing medicines during the development of a new product.
The Pharmaceutical Supply & Engineering Sciences (PSES) team is responsible for scaling up and optimizing formulations and processes leading to the successful clinical production of new Drug Products (DP). The PSES DP Pilot Plant comprises two operational areas: Solids area (oral solid dosage forms) and Liquids & Parenterals area (early development of liquid and parenteral products for both Small Molecules and Large Molecules).
What you will do. As an operator, you will independently perform clinical production activities. Product quality is always important, but in a sterile environment, it requires an even higher level of attention. Technical competencies, GMP knowledge, and experience with aseptic production techniques are considered essential qualifications.
Responsibilities.
- Execute experimental and clinical batches of liquid and parenteral products, including the assembly, sterilization, and operation of the equipment.
- Translate development processes into safe, efficient, and scalable production processes and support technology transfers.
- Collaborate with Process Engineers to establish work instructions and procedures and document batch results and process knowledge.
- Optimize processes and equipment, act as equipment system owner, and support qualifications.
- Implement new technologies, train colleagues, and ensure compliance with current GMP requirements, including high-quality aseptic handling.
Profile
- Bachelor's level or equivalent through experience.
- Experience working in a GMP environment is required.
- Experience in a sterile production environment (C-zone) is required.
- Ability to work accurately and independently in a highly complex and dynamic environment.
- Eager to learn, with a positive attitude and a proactive mindset.
- Strong team player who collaborates effectively within a team of eight operators.
- Strong communication skills in both Dutch and English.
- Proficient in using standard Microsoft Office applications and various other digital applications.
How to apply
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