Specialist, Cleaning Validation | Specialist (m/w/d) Cleaning Validation
Roche Diagnostics GmbH
Job Summary
This role involves acting as an experienced Specialist responsible for the validation, verification, and risk assessment of cleaning procedures for process plants and standard equipment within Diagnostics Operations Penzberg. A significant focus will be on contributing to large Capital Expenditure (CAPEX) investment projects. Day-to-day tasks include ensuring cleaning validity in compliance with relevant Quality regulations (GxP, ISO 13485, 21 CFR Part 820) and project timelines, collaborating effectively with Quality Assurance (QA) interfaces, and maintaining clear communication with internal and external stakeholders. The specialist will also contribute expertise to equipment qualification issues and ensure economically sound decision-making within major projects. This position requires a scientific background and substantial experience (3+ years) in cleaning validation, ideally within the chemical, diagnostic, or pharmaceutical industry, demanding a structured approach and strong coordination skills for a modern Quality Management environment. This is a full-time, 5-year fixed-term contract requiring at least 50% on-site presence.
Required Skills
Education
Completed natural science degree or comparable qualification/training
Experience
- At least 3 years of specific professional experience in (chemical) production
- More than 3 years of relevant experience in production
- Mandatory profound previous experience in cleaning validation, ideally in the chemical, diagnostic, and/or pharmaceutical industry
- Experience with project environment procedures
Languages
Additional
- This is a 5-year fixed-term contract. Requires at least 50% on-site presence.
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