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  • 1 month ago

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Position: Validation engineer (f/m/d)
Location: Thörishaus
Position Summary

The role within the Manufacturing, Science and Technology team (MSAT) is responsible for developing a core competency in process-, cleaning- and shipping validation for biotechnological products at late phase clinical trial material production through Process Performance Qualification (PPQ) campaigns, and commercial production, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Support Engineers.

This position incorporates continued process verification on commercial products and supporting technical problem solving. This role may have other validation responsibilities as assigned, but will primarily be in charge of process validation planning, validation execution support, retrieve process data, analysing of the data, look for positive and adverse trends, correlate the findings, solve issues as noted by the data analysis for process improvement... refinement, and create written reports about the exercise.

What you can expect

- Perform all functions associated with process-, cleaning- and shipping validation (strategy, planning, writing of plans/ protocols, execution support, reports)
- Author and lead process risk analysis, critical process parameter and critical quality attributes identification and define process control strategy
- Provide data, analyses, write-ups, reviews, and other input to annual Product Quality Reviews (PQR)
- Perform process monitoring (control charts) and statistical process analysis including authoring of continued process verification reports (CPV)
- Represent as Validation Subject Matter Expert (SME) on global project teams and validation councils
- Represent as Validation SME on internal teams (e.g. Deviation and project meetings)
- Participate in internal, customer and regulatory inspections
- Author and support of deviations/ investigations and change controls in manufacturing
- Make recommendations for process changes and sponsor these to the larger process team
- Support Technology Transfer projects as receiving or sending process SME
- Actively drive Operational Excellence and Environmental Health and Safety improvements

Your skills and qualifications

- Bachelors degree or higher in Life Sciences, Graduates are very welcome
- Highly autonomous and initiative
- Excellent written (especially technical writing) and verbal communication skills in German and English

- Experience with mid and large-scale process- and cleaning validation in GMP regulated Life Science industry (preferably Biotech) is a plus
- Disposable technology and cell culture experience is a plus

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile MSAT team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills. Additionally, we offer an extensive benefits package and a competitive compensation package.

Are you interested in joining our mission? We look forward to receiving your application
Thörishaus Switzerland


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