MSIT Innovation Specialist
Vor 4 Tagen
In the Manufacturing Science Innovation & Technology team, we are seeking a skilled professional to join our ranks as an MSIT Engineer. As a key member of our multidisciplinary team, you will be responsible for executing project activities in various areas of biopharmaceutical processes within the Late Stage Development department.
This role offers a unique opportunity to work with new areas and challenges, expanding your expertise in GMP related MSIT work. You will perform technical tasks under the general supervision of experienced Subject Matter Experts, providing you with knowledge of specific areas and enabling you to expand your skills further.
If you are looking for a diverse role that allows you to learn about GMP processes from multiple angles, this is the ideal position for you.
Key Responsibilities:
- Collaborate on implementation projects for Drug Substance or Drug Product under GxP for vaccine and other product production.
- Represent MSIT functions in project teams.
- Deliver specific project tasks based on project milestones/priorities according to area of expertise.
- Write documents and support document readiness for activities in production units.
- Evaluate product/process performance and deviations, troubleshooting, performance of change activities, tracking, and reporting key production and quality indicators against established metrics.
- Propose new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety, and regulatory compliance.
- Collaborate with GMP Operations for investigations, change controls, data verification, and process improvements.
- Lead specific Qualification and Validation project activities related to manufacturing processes, equipment, and cleanrooms.
Requirements:
- Bachelor's/Master's degree in Engineering, Biotechnology, Food Technology, Biology, or a similar discipline.
- Work experience in a pharmaceutical company is highly valued.
- General knowledge of GMP.
- Flexible team player with the ability to prioritize.
- Interest in working in different teams open to challenges and new topics.
- Accurate working and documentation style.
- Analytical thinking and problem-solving ability.
- Good communication in German and English.
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