For our client, a global leader in the pharmaceutical industry, we are seeking a Validation Expert (Cleaning Validation) to join their team in Switzerland, Kaiseraugst. This is an incredible opportunity to work in an unlimited role with a leading company and contribute to global health.
General Information:
Start date: ASAP
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:
As a Validation Expert, you’ll be joining the Center of Excellence for Cleaning Validation. The Center of Excellence Cleaning Validation is responsible for providing scientific evidence 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 sample analysis in our laboratories using techniques such as HPLC, ELISA, TOC, and MS. The trace analysis used is both developed and validated in-house. Our 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 our client has close ties to pharmaceutical production and is also a center of excellence for trace analysis.
Your Profile:
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, in particular laboratories and value streams, for the practical implementation and documentation of all cleaning validation sample trains
Organization and implementation of sample trains, 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 implementation of cleaning validation activities in compliance with all GMP specifications and processes
Ensuring that customer requirements in the area of production in connection with cleaning validation are met
Analyses, risk assessments and process optimization
Carrying out risk assessments on cleaning topics
Support with ADC monitoring, spill and small-scale studies as well as cleaning assessments
Support with launches and technical transfers in the area of cleaning validations.
Troubleshooting in cleaning-related production processes, root cause analysis and preparation of quality assessments regarding product quality (Product Quality Impact Assessments)
Contact person (DOC SPOC) and subject matter expert (SME) for PQS documents
Supporting and implementing suggestions for improvement and process optimizations
Collaboration and teamwork
Compliance with guidelines on safety, health and the environment (SHE)
Promoting and supporting 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:
Completed studies 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
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, process optimization projects and troubleshooting
Fluent German and good English skills.
Nice to haves:
Experience in EVAL
Sounds interesting? Apply now — we’re looking forward to receiving your applications!
For our client, a global leader in the pharmaceutical industry, we are seeking a Validation Expert (Cleaning Validation) to join their team in Switzerland, Kaiseraugst. This is an incredible opportunity to work in an unlimited role with a leading company and contribute to global health.
General Information:
Start date: ASAP
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:
As a Validation Expert, you’ll be joining the Center of Excellence for Cleaning Validation. The Center of Excellence Cleaning Validation is responsible for providing scientific evidence 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 sample analysis in our laboratories using techniques such as HPLC, ELISA, TOC, and MS. The trace analysis used is both developed and validated in-house. Our 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 our client has close ties to pharmaceutical production and is also a center of excellence for trace analysis.
Your Profile:
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, in particular laboratories and value streams, for the practical implementation and documentation of all cleaning validation sample trains
Organization and implementation of sample trains, 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 implementation of cleaning validation activities in compliance with all GMP specifications and processes
Ensuring that customer requirements in the area of production in connection with cleaning validation are met
Analyses, risk assessments and process optimization
Carrying out risk assessments on cleaning topics
Support with ADC monitoring, spill and small-scale studies as well as cleaning assessments
Support with launches and technical transfers in the area of cleaning validations.
Troubleshooting in cleaning-related production processes, root cause analysis and preparation of quality assessments regarding product quality (Product Quality Impact Assessments)
Contact person (DOC SPOC) and subject matter expert (SME) for PQS documents
Supporting and implementing suggestions for improvement and process optimizations
Collaboration and teamwork
Compliance with guidelines on safety, health and the environment (SHE)
Promoting and supporting 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:
Completed studies 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
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, process optimization projects and troubleshooting
Fluent German and good English skills.
Nice to haves:
Experience in EVAL
Sounds interesting? Apply now — we’re looking forward to receiving your applications!
