Validation Expert (m/f/d) – Cleaning Validation / Quality and Validation / GMP-Regulated Environment / Communication Skills / Team Orientation / Data Analysis / Process Optimization / EVAL Roche / Troubleshooting / German
Project / Role:
For our client, a large pharmaceutical company based in Basel, we are looking for a Validation Expert (m/f/d).
Background:
The Center of Excellence Cleaning Validation is responsible for scientifically proving that the cleaning process of production equipment in contact with the product can remove all residues to ensure that no cross-contamination occurs. 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. Our clients include all value streams in Kaiseraugst, Basel Biotech and parts of the IMP area. In the Competence Center for Cleaning Validation, you have numerous opportunities for further training, as we have a close connection to pharmaceutical production and are a competence center for trace analysis. The polyvalent work and further development distinguishes us.
The perfect candidate will preferably have a completed technical degree with a doctorate and experience in cleaning validation.
Tasks & 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 requirements are met in the area of production related to cleaning validation.
* Analyses, risk assessments and process optimization
* Conducting risk assessments on cleaning topics.
* Support for ADC monitoring, spill and small-scale studies as well as cleaning assessments.
* Support for launches and technical transfers in the area of cleaning validations.
* Troubleshooting cleaning-related production processes, root cause analysis and preparation of product quality assessments (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.
Must Haves:
* Degree in pharmacy, chemistry, biotechnology or a comparable scientific discipline, preferably with a doctorate
* Min. 2 years of experience in cleaning validation, especially in a GMP-regulated environment
* Sound knowledge of regulatory requirements in the field 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, process optimization projects and troubleshooting
* Good English & fluent German skills
Nice to haves:
* Experience in EVAL Roche
Reference nr.: 924365SDA
Role: Validation Expert (m/f/d)
Industry: Pharma
Location: Kaiseraugst
Workload: 100 %
Start: asap
Duration: unlimited
Application deadline: 25.08.2025
Job Type: 100%
Language:
- German (Required)
Work Location: On the road
