350 Lilly Deutschland GmbH
Associate Director TSMS Sterility Assurance(m/w/x)
Vollzeitnur vor OrtManagement
Alzey
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
LILilly
Associate Director - Validation TS/MS(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Sterilization and cleaning validation for life-changing medicines. Extensive validation and team leadership experience required. Accommodation for individuals with disabilities, equal employment opportunities.
Anforderungen
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- Understanding of GMPs and manufacturing processes
- Experience in building and leading a team
- Extensive knowledge of equipment qualification and/or cleaning, decontamination, sterilization process validation
- Strong knowledge of risk management and ability to use risk assessment tools as part of validation strategy
- Ability to analyze complex data and solve problems
- Strong technical writing and presentation skills
- Fluent in English
- English Resume only
- Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)
- Able to communicate in German
Aufgaben
- Maintain a safe work environment
- Support HSE corporate and site goals
- Build and lead a team aligned with Lilly values
- Plan and execute sterilization validation
- Conduct cleaning validation
- Perform filter validation
- Execute shipping validation
- Complete temperature mapping
- Develop robust revalidation systems
- Coordinate with engineering, operations, and quality
- Ensure correct governance for validation activities
- Manage stakeholders and leadership team
- Align with operational planning
- Coach team for technical development
- Own validation concepts
- Ensure network alignment
- Investigate complex validation deviations
- Guide product impact assessments
- Review completed validation packages
- Compile and analyze validation data
- Manage external contracts and resources
- Present validation topics during inspections
- Stay updated on validation requirements
- Follow industry best practices
- Benchmark within the Lilly network
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Accommodation for individuals with disabilities
- Equal employment opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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LILilly
Associate Director - Validation TS/MS(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Sterilization and cleaning validation for life-changing medicines. Extensive validation and team leadership experience required. Accommodation for individuals with disabilities, equal employment opportunities.
Anforderungen
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- Understanding of GMPs and manufacturing processes
- Experience in building and leading a team
- Extensive knowledge of equipment qualification and/or cleaning, decontamination, sterilization process validation
- Strong knowledge of risk management and ability to use risk assessment tools as part of validation strategy
- Ability to analyze complex data and solve problems
- Strong technical writing and presentation skills
- Fluent in English
- English Resume only
- Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)
- Able to communicate in German
Aufgaben
- Maintain a safe work environment
- Support HSE corporate and site goals
- Build and lead a team aligned with Lilly values
- Plan and execute sterilization validation
- Conduct cleaning validation
- Perform filter validation
- Execute shipping validation
- Complete temperature mapping
- Develop robust revalidation systems
- Coordinate with engineering, operations, and quality
- Ensure correct governance for validation activities
- Manage stakeholders and leadership team
- Align with operational planning
- Coach team for technical development
- Own validation concepts
- Ensure network alignment
- Investigate complex validation deviations
- Guide product impact assessments
- Review completed validation packages
- Compile and analyze validation data
- Manage external contracts and resources
- Present validation topics during inspections
- Stay updated on validation requirements
- Follow industry best practices
- Benchmark within the Lilly network
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Accommodation for individuals with disabilities
- Equal employment opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Lilly
Branche
Pharmaceuticals
Beschreibung
The company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need.
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