Validation Expert
m / f / d, Aargau
The Center of Excellence Cleaning Validation is responsible for providing scientific evidence that the cleaning process of production equipment in contact with the product can remove all residues to ensure that cross-contamination does not occur. Validation is based on toxicological data, sampling, and analysis of samples in our laboratories using techniques such as HPLC, ELISA, TOC, and MS. The trace analysis used is both developed and validated in-house.
Contract duration : Min 1 year / will be extended
Workload : 100%
Possible on-call service
The ideal candidate will preferably have a completed technical degree with a doctorate and experience in cleaning validation.
Responsibilities :
1. Responsibility for cleaning validation.
2. Development, implementation, and monitoring of the cleaning validation concept.
3. Cooperation with internal and external interfaces, in particular laboratories and value streams, for practical implementation and documentation of all cleaning validation samples.
4. Organization and execution of sample pulls, sample preparation, evaluation, and documentation of cleaning validation samples.
5. Creation and maintenance of plans, reports, sample train protocols, and SOPs.
6. Responsibility for timely execution of cleaning validation activities in compliance with GMP specifications and processes.
7. Ensuring customer production requirements related to cleaning validation are met.
8. Analyses, risk assessments, and process optimization.
9. Conducting risk assessments on cleaning issues.
10. Support with ADC monitoring, spill and small-scale studies, and cleaning assessments.
11. Support for launches and technical transfers in cleaning validation.
12. Troubleshooting cleaning-related production processes, root cause analysis, and preparation of product quality impact assessments.
13. Serving as contact person (DOC, SPOC) and subject matter expert (SME) for PQS documents.
14. Supporting and implementing suggestions for improvement and process optimization.
15. Collaboration and teamwork.
16. Compliance with safety, health, and environmental (HSE) guidelines.
17. Promoting teamwork and a strong team spirit, while also working independently.
18. Ensuring smooth information flow within the team and with relevant interfaces.
Requirements :
1. Degree in pharmacy, chemistry, biotechnology, or a comparable scientific discipline, preferably with a doctorate.
2. Fluent in German and English.
3. Minimum 2 years of experience in cleaning validation, especially in a GMP-regulated environment.
4. In-depth knowledge of regulatory requirements in quality and validation.
5. Strong analytical skills, with a structured and independent working style.
6. Excellent communication skills and team orientation, with the ability to work effectively in a multidisciplinary environment.
7. Experience with data analysis, process optimization projects, and troubleshooting.
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