Overview
Validation Expert Jobs in Kaiseraugst, Aargau, Switzerland at Randstad Switzerland
Title: Validation Expert
Company: Randstad Switzerland
Location: Kaiseraugst, Aargau, Switzerland
For our client, a leading pharmaceutical company in Switzerland, we are looking for a Validation Expert.
General Information:
Start date: ASAP
Latest start date: 01.09.2025
Duration: unlimited
Workplace: Kaiseraugst
Workload: 100%
Team: 20 people
Department: Engineering Science and Technology (MMMCG)
Working hours: Standard
On-call duty: Yes, throughout the year
About the job:
The Center of Excellence Cleaning Validation is responsible for scientifically demonstrating that the cleaning process of product contact production equipment 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 techniques such as HPLC, ELISA, TOC, and MS. The trace analysis used is both developed and validated in-house. Our client’s customers span all value streams in Kaiseraugst, Basel Biotech, and parts of the IMP sector. At the Cleaning Validation Competence Center, you have numerous opportunities for further training, as we have close ties to pharmaceutical production and are also a center of excellence for trace analysis.
Tasks & responsibilities:
Collaboration with internal and external interfaces (especially laboratories and value streams), practical implementation and documentation of all cleaning validation sample trains in the plants
Sampling, sample preparation, compilation, evaluation and documentation of the results of the cleaning validation sample trains carried out
Creating/maintaining plans, reports, sample train protocols and SOPs
Ensuring timely cleaning validation activities in compliance with all GMP requirements and processes
Ensuring that customer requirements in production are met in relation to the RV
Risk assessments on the subject of cleaning
ADC monitoring, spill and small scale studies, cleaning assessments
Launches / tech transfers in the area of ​cleaning validations
Troubleshooting in cleaning-related production processes, conducting root cause analyses, creating product quality impact assessments
DOC SPOC, SME for PQS documents
Supporting suggestions for improvement and process optimizations
Compliance with SGU guidelines
Supporting team spirit and teamwork for independent work
Ensuring a sufficient flow of information within the team and with interfaces
Must Haves:
Min. completed vocational training, university degree preferred
Min. 2 years of practical professional experience in the area of ​cleaning validation within a pharmaceutical production, particularly in handling samples
Min. 2 years of professional experience in a GMP regulated working environment
Experience in interface communication
Interest in analytics
Willingness to constantly develop further and take on new tasks
A high Team player
Agile and creative mindset
Flexibility, agility and the will to implement a lean culture
Good English & fluent German skills
Nice to haves:
EVAL
Next steps
Interviews: 1. Virtual, 2. Onsite
Sounds interesting? Apply now – we’re looking forward to receiving your applications!