Project Engineer (Pharma) | Chemieingenieur (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
As a Project Engineer at Daiichi Sankyo in Pfaffenhofen, you will play a pivotal role in the design and implementation of process and utility systems, specifically supporting a new sterile filling and bioconjugation facility. Your day-to-day responsibilities include managing technical projects, developing concepts and user requirement specifications (URS), and overseeing the full lifecycle of facility qualifications, including FATs and SATs. You will act as a key technical partner to production teams, assisting with troubleshooting, GMP-compliant deviation management, CAPA implementation, and change control processes. Additionally, you will contribute to the digitalization and automation of process equipment while collaborating closely with internal stakeholders and external suppliers. This role is ideal for an experienced engineer looking to make a meaningful impact in a global healthcare company committed to innovative therapies, offering a unique opportunity to work on large-scale infrastructure projects in a highly regulated pharmaceutical environment.
Required Skills
Education
University degree in Engineering or a comparable qualification.
Experience
- More than 5 years of professional experience in leading, planning, and executing projects within the pharmaceutical industry.
- Professional experience in sterile filling, freeze-drying, or bioconjugation processes is considered an advantage.
- Proven experience in managing GMP-regulated environments and implementing corrective and preventive actions (CAPA).
Languages
Additional
- Not specified
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