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Process Engineer Manufacturing (gn) Drug Products Bulk, Drug substances, Fill & Finish
deutschlandweit (Home-Office)
Aktualität: 04.12.2021


04.12.2021, via OPTARES GmbH & Co. KG
deutschlandweit (Home-Office)
Process Engineer Manufacturing (gn) Drug Products Bulk, Drug substances, Fill & Finish
Leading technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing and ensure on-time execution for manufacturing processes of his discipling (e.g. DS), incl. GMP documentation for regulatory approval Designing and conducting process qualification and validation and driving continuous improvement of process robustness Monitoring for our clients product and process parameters Leading end-to-end change control management (e.g., working with Technology Development, Regulatory, QA) Investigating and problem solving upcoming process issues Supporting new process design and risk assessment for new initiatives Providing support on technical processes to other teams, share Lessons Learnt
University degree in (Life) Science or Engineering Practical experience in the life science industry Several years of practical experience and expertise in Drug Products Bulk (DP), Drug substances or Fill & Finish process engineering Experience with methods for technology transfer comparability assessments and process performance qualification Profound knowledge of EU/ US GMP guidelines and regulatory standards Strategic and analytical thinking skills to identify risks and prepare balanced decisions Excellent process management skills, Lean and Six Sigma qualifications preferred Creativity and the ability to develop a flexible approach to changing conditions, distinct analytical and conceptual competencies High team spirit and excellent collaborating skills Good communication skills, fluency in German and English




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