Process Engineer (m/f) Aseptic pharmaceutical production - Germany
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- Everyone achieves greatness at our company.
- As one of the most rapidly growing biotechnology companies in Europe, we’re working on revolutionary approaches in the fight against cancer and other diseases.
- Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future.
- You too can become a pioneer! Here, you’ll achieve greatness
- As a part of our lighthouse project, you will soon take the next critical step with us.
- With our company, you will become a worldwide forerunner in the development of a completely new type of immunotherapy against cancer using individualized tumor vaccines.
Your duties in detail:
- Soon you will be responsible for developing and activating a manual production system for individualized cancer vaccines in isolators and ensuring that the GMP production process runs smoothly.
- Of course, you will also help improve the manual production process and create production and operation manuals as well as standard operating procedures (SOPs).
- Additionally, you will be implementing production plans and respond flexibly and creatively to new demands. You will recognize the reasons for any possible deviations and implement design strategies for improving the process steps. CAPAs will be completed on schedule.
- Working closely with other departments and interdisciplinary teams, you will qualify the production equipment and validate the production process.
- Once you have displayed your skills in these areas, you will take on additional responsibilities in a leadership role.
What you have to offer.
- A degree in engineering sciences, specializing in bioprocess engineering, pharmacy, chemistry or in a field in the food industry would be an advantage
- Several years of solid professional experience in the aseptic production of pharmaceutical agents under GMP conditions as well as profiency in systematic error analysis. A further advantage is experience in quality assurance and assessing equipment
- Experience in the optimization of production processes and creation of production manuals and standard operating procedures (SOPs) in a GMP environment in both German and English
- Highly developed expertise and communication skills required to work with qualification and validation processes as well as to train and manage employees
- Willingness to work flexible hours and to accept shift work (including on weekends and holidays)