Dein persönlicher KI-Karriere-Agent
Authoring and adapting MES/PCS recipes for sterile drug product manufacturing. MES recipe authoring experience required. Relocation assistance provided.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – ist ein Plus
- Englisch – ist ein Plus
Tools & Technologien
- Emerson Syncade
- DeltaV
- cGMP
- 21CRF part 11
Benefits
Sonstige Vorteile
- Relocation assistance
Gefällt dir diese Stelle?
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Authoring and adapting MES/PCS recipes for sterile drug product manufacturing. MES recipe authoring experience required. Relocation assistance provided.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – ist ein Plus
- Englisch – ist ein Plus
Tools & Technologien
- Emerson Syncade
- DeltaV
- cGMP
- 21CRF part 11
Benefits
Sonstige Vorteile
- Relocation assistance
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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