Validation Expert m/f/d, AargauThe 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 e.g. HPLC, ELISA, TOC and MS techniques. 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 perfect candidate will preferably have a completed technical degree with a doctorate and experience in cleaning validation.Responsibilities: - Responsibility for cleaning validation
- Development, implementation and monitoring of the cleaning validation concept.
- Cooperation with internal and external interfaces, in particular laboratories and value streams, for the practical implementation and documentation of all cleaning validation samples.
- Organization and execution of sample pulls, sample preparation as well as evaluation and documentation of the results of the cleaning validation samples.
- Creation and maintenance of plans, reports, sample train protocols and SOPs.
- Responsibility for the timely execution of cleaning validation activities in compliance with all GMP specifications and processes.
- Ensuring that customer production requirements related to cleaning validation are met.
- Analyses, risk assessments and process optimisation
- Conducting risk assessments on cleaning issues.
- Support with ADC monitoring, spill and small-scale studies as well as cleaning assessments.
- Support for launches and technical transfers in the field of cleaning validations.
- Troubleshooting cleaning-related production processes, root cause analysis and preparation of product quality impact assessments.
- Contact person (DOC, SPOC) and subject matter expert (SME) for PQS documents.
- Support and implementation of suggestions for improvement and process optimization.
- Collaboration and teamwork
- Compliance with safety, health and environmental (HSE) guidelines.
- Promotion and support of teamwork and a strong team spirit, while at the same time being able to work independently.
- Ensuring a smooth flow of information within the team and with relevant interfaces.
Requirements: - Degree in pharmacy, chemistry, biotechnology or a comparable scientific discipline, preferably with a doctorate
- Fluent German and English
- Min. 2 years of experience in cleaning validation, especially in a GMP regulated environment
- In-depth knowledge of regulatory requirements in the area of quality and validation
- Strong analytical skills, combined with a structured and independent way of working
- Strong communication skills and team orientation, as well as the ability to work effectively in a multidisciplinary environment
- Experience with data analysis, projects for process optimization and troubleshooting
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