Project Validation Specialist | Specialist (m/w/d) Project Validation
Simtra Deutschland GmbH
Job Summary
As a Project Validation Specialist based in Halle (Westfalen), you will play a critical role in the pharmaceutical production of life-saving cancer treatments. Your day-to-day responsibilities involve the end-to-end management of validation processes, specifically focusing on process, filter, and cleaning validation, as well as Extractables & Leachables studies. You will be responsible for planning, coordinating, and documenting (re-)validations for both internal and client-driven projects. This includes creating validation plans and reports (primarily in English), conducting risk analyses, and maintaining validation instructions. A key part of the role involves representing validation concepts during audits and inspections and addressing any subsequent findings. This position is particularly attractive due to its integration into a highly regulated aseptic manufacturing environment, offering a 37.5-hour work week, 30 days of vacation, and a comprehensive benefits package including a 13th-month salary and relocation support.
Required Skills
Education
Completed degree in Pharmaceutical Technology, Biotechnology, or another natural science field of study.
Experience
- Proven professional experience in a comparable validation position within the pharmaceutical industry
- Practical experience in the aseptic manufacturing of medicinal products
- Experience in creating validation plans, reports, and risk assessments
- Experience presenting validation results and concepts during audits and inspections
Languages
Additional
- The role requires working at the production site in Halle (Westfalen). Candidates must be able to handle documentation primarily in English and participate in audits.
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