Validation Expert (m/f/d)

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