CH12 Lonza AG
MES/DeltaV Specialist(m/w/x)
Full-timeOn-siteNot specified
Visp
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Authoring and adapting MES/PCS recipes for sterile drug product manufacturing. MES recipe authoring experience required. Relocation assistance provided.
Requirements
- Studies in Pharmaceutical Technology, Chemistry, or Pharmacy
- Experience in MES recipe authoring
- Process knowledge in sterile drug product area
- Knowledge of DeltaV
- Familiarity with regulated environment, cGMP, 21CRF part 11, validation requirements
- Proficiency in German and English
- Familiarity with GMP requirements, quality procedures, SOP execution
- Good interpersonal skills and interaction with organizational interfaces
- Structured, focused, and well-organized working demeanor
- Motivation, drive, and problem-solving attitude
Tasks
- Author and adapt MES/PCS recipes for drug product processes
- Define overall concept for MES recipes to ensure easy and fast creation
- Build and maintain GMP documents (IQ, OQ, PQ, etc.)
- Provide front-line MES support to manufacturing teams, plant engineers, and QA operations
- Train all end users on MES
- Act as MES subject matter expert during customer audits and visits
- Maintain MES at inspection readiness level
- Lead process-related investigations and critical deviations
- Assist in decision-making on production issues
- Lead process changes and CAPAs within required timelines
- Conduct CAPA efficiency checks
- Implement innovation and improvement projects for the production plant
Education
- Bachelor's degree
Languages
- German – is a plus
- English – is a plus
Tools & Technologies
- Emerson Syncade
- DeltaV
- cGMP
- 21CRF part 11
Benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Authoring and adapting MES/PCS recipes for sterile drug product manufacturing. MES recipe authoring experience required. Relocation assistance provided.
Requirements
- Studies in Pharmaceutical Technology, Chemistry, or Pharmacy
- Experience in MES recipe authoring
- Process knowledge in sterile drug product area
- Knowledge of DeltaV
- Familiarity with regulated environment, cGMP, 21CRF part 11, validation requirements
- Proficiency in German and English
- Familiarity with GMP requirements, quality procedures, SOP execution
- Good interpersonal skills and interaction with organizational interfaces
- Structured, focused, and well-organized working demeanor
- Motivation, drive, and problem-solving attitude
Tasks
- Author and adapt MES/PCS recipes for drug product processes
- Define overall concept for MES recipes to ensure easy and fast creation
- Build and maintain GMP documents (IQ, OQ, PQ, etc.)
- Provide front-line MES support to manufacturing teams, plant engineers, and QA operations
- Train all end users on MES
- Act as MES subject matter expert during customer audits and visits
- Maintain MES at inspection readiness level
- Lead process-related investigations and critical deviations
- Assist in decision-making on production issues
- Lead process changes and CAPAs within required timelines
- Conduct CAPA efficiency checks
- Implement innovation and improvement projects for the production plant
Education
- Bachelor's degree
Languages
- German – is a plus
- English – is a plus
Tools & Technologies
- Emerson Syncade
- DeltaV
- cGMP
- 21CRF part 11
Benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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