Are you looking for a dynamic, globally active technology CDMO - yet at the same time, you appreciate a value-oriented, trusting company?
At our Amsterdam-based center Wacker Biotech B.V. focuses on the GMP-compliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product. We are currently looking for:
Besides being involved in production the Process Lead Upstream/Downstream Processing is involved in the introduction of the new client processes into the manufacturing organisation. This means writing process documentation, training, and coaching of operators on the execution of the process. You will be working on all our produced pharmaceutical products (vaccines, protein, polysaccharide and live microbial). This variation in activities and the fact that operators work in both the Upstream and Downstream part of the process make that you will work on a high amount of different systems and process steps.
- You are a Subject Matter Expert (SME) with respect to client projects and directly involved in scale up, writing process documentation, training, and coaching of operators on the execution of the process;
- Execution of activities for GMP production such as buffer preparation, washing, build-up of sterile goods according to procedure and planning;
- Execution of routine activities on the complex systems within the departments according to the procedures and planning;
- Perform all process activities in accordance with FDA/GMP guidelines;
- Ownership of their own training requirements (Basic Operator, additional training on topics such as deviations, review, writing documentation);
- Ownership regarding Health & Safety. Following procedures, wearing proper safety gears, communicate unsafe or unhealthy situations. Initiates or revise procedures to improve Health and Safety environment;
- You are a Subject Matter Expert (SME) with respect to production equipment and directly involved in maintenance, validation, and calibration of this equipment;
- Takes initiative to complete internal projects or deviations within the agreed timelines.
- At least an MBO/HBO level of education with relevant technical and at least USP/DSP process experience;
- Quality-conscious, flexible, and proactive;
- Experience in working under GMP guidelines;
- Team player with a high degree of autonomy;
- High priority on personal hygiene;
- Analytical, accurate and structured;
- Willing to work in shifts (three shifts from Monday to Friday);
- Good (Dutch) and English written and oral communicative skills;
- Experience in the (bio) pharmaceutical Industry;
- You reside in and are eligible to work in The Netherlands (valid work permit).
Sustainability is one of WACKER's corporate goals - also as an employer. We want you to remain productive, healthy and successful long term. That is why we offer, for example, comprehensive health management and a variety of advanced training programs and courses for individual development opportunities, alongside a good work-life balance. Naturally, we also have a fair compensation system and above-average social benefits. After all, social responsibility has a long tradition at WACKER.
T: 06 33 13 77 46
When interested please react through the application process with your English resume.
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