Senior Director – Global Learning & Development, Performance & Organisational Effectiveness

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 the scientific proof that the cleaning process of product-contacting production equipment can remove all residues to ensure that no cross-contamination occurs. The validation is based on toxicological data, sampling, and analysis of samples in our laboratories using, for example, HPLC, ELISA, TOC, and MS techniques. The trace analytics used are both self-developed and self-validated. Our customers include all value streams in Kaiseraugst, Basel Biotech, and parts of the IMP area. In the Cleaning Validation Competence Center, you have numerous opportunities for further training, as we have a close connection to pharmaceutical production and are also a competence center for trace analytics. The versatile work and further development characterize us.

The perfect candidate has a completed technical degree, preferably with a doctorate, and experience in cleaning validation.

Tasks & Responsibilities:
* Responsibility for cleaning validation
* Development, implementation, and monitoring of the cleaning validation concept.
* Collaboration with internal and external interfaces, especially laboratories and value streams, for the practical execution and documentation of all cleaning validation sample withdrawals.
* Organization and execution of sample withdrawals, sample preparation, as well as evaluation and documentation of the results of cleaning validation samples.
* Creation and maintenance of plans, reports, sample withdrawal protocols, and SOPs.
* Responsibility for the timely execution of cleaning validation activities in compliance with all GMP requirements and processes.
* Ensuring that customer requirements in the production area related to cleaning validation are met.
* Analyses, risk assessments, and process optimization
* Conducting risk assessments on cleaning topics.
* Support in ADC monitoring, spill and small-scale studies, as well as cleaning assessments.
* Support in launches and technical transfers in the area of cleaning validations.
* Troubleshooting in cleaning-related production processes, root cause analysis, and creation of quality assessments regarding product quality (Product Quality Impact Assessments).
* Contact person (DOC SPOC) and subject matter expert (SME) for PQS documents.
* Support and implementation of improvement proposals and process optimizations.
* Collaboration and teamwork
* Compliance with safety, health, and environmental (SHE) guidelines.
* Promotion and support of teamwork and a strong team spirit, while also being capable of working independently.
* Ensuring smooth information flow within the team and with relevant interfaces.

Must Haves:
* Completed studies in pharmacy, chemistry, biotechnology, or a comparable scientific discipline, preferably with a doctorate
* Minimum 2 years of experience in cleaning validation, especially in a GMP-regulated environment
* Profound knowledge of regulatory requirements in quality and validation
* Strong analytical skills combined with a structured and independent working style
* 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 no.: 924365SDA
Role: Validation Expert (m/f/d)
Industry: Pharma
Location: Kaiseraugst
Workload: 100 %
Start: asap
Duration: permanent
Application deadline: 25.08.2025

If this position has sparked your interest, please send us your complete dossier via this advertisement or via email. If this position does not fit your profile well and you wish to receive other positions directly, you can also send us your dossier via this advertisement or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: +41 41 760 77 01.

About us:
ITech Consult is a Swiss company certified according to ISO 9001:2015 with branches in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for personnel leasing in the fields of IT, Life Science & Engineering.
We offer personnel leasing & payroll services. For our candidates, this is free of charge; even with payroll, we do not charge any additional fees.

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