350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
LILilly Deutschland GmbH
Sterility Assurance Advisor – Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading sterility assurance for parenteral products, optimizing process control strategies. In-depth knowledge of GMPs and microbiology required. Accommodation for individuals with disabilities.
Anforderungen
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- In-depth knowledge of GMPs and internal standards
- In-depth knowledge of parenteral processing
- In-depth knowledge of microbiology and sterility assurance
- In-depth knowledge of risk management and risk assessment tools
- Ability to analyze complex data and solve problems
- Strong technical writing and presentation skills
- Teamwork and interpersonal skills
- Ability to effectively influence
- Facility start-up and/or technical transfer experience
- Environmental monitoring performance qualification experience
- Aseptic process simulations experience
- Prior experience in parenteral product manufacture functions
- Advanced Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Aufgaben
- Lead technical initiatives in sterility assurance for parenteral products
- Develop and implement a technical agenda for reliable manufacturing
- Enhance process control strategies and optimize technologies
- Deepen scientific understanding of sterility assurance
- Maintain a safe work environment and support HSE goals
- Understand scientific principles of parenteral drug manufacturing
- Evaluate manufacturing processes for contamination risks
- Lead or participate in complex sterility assurance projects
- Develop and execute facility monitoring strategies
- Conduct root cause analysis for major deviations
- Stay updated on regulatory requirements for sterility assurance
- Influence corporate guidance on sterility assurance
- Identify and implement continuous improvements
- Provide design input for new processes and facilities
- Represent sterility assurance programs during audits and inspections
- Assist in writing regulatory submissions
- Create and approve sterility assurance training materials
- Mentor less senior scientists within TS/MS
- Mentor less senior cross-functional personnel
- Provide technical consultation across the Parenteral Network
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Sonstige Vorteile
- Accommodation for individuals with disabilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly Deutschland GmbH 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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VollzeitVor OrtSenior
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Leading sterility assurance for parenteral products, optimizing process control strategies. In-depth knowledge of GMPs and microbiology required. Accommodation for individuals with disabilities.
Anforderungen
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- In-depth knowledge of GMPs and internal standards
- In-depth knowledge of parenteral processing
- In-depth knowledge of microbiology and sterility assurance
- In-depth knowledge of risk management and risk assessment tools
- Ability to analyze complex data and solve problems
- Strong technical writing and presentation skills
- Teamwork and interpersonal skills
- Ability to effectively influence
- Facility start-up and/or technical transfer experience
- Environmental monitoring performance qualification experience
- Aseptic process simulations experience
- Prior experience in parenteral product manufacture functions
- Advanced Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Aufgaben
- Lead technical initiatives in sterility assurance for parenteral products
- Develop and implement a technical agenda for reliable manufacturing
- Enhance process control strategies and optimize technologies
- Deepen scientific understanding of sterility assurance
- Maintain a safe work environment and support HSE goals
- Understand scientific principles of parenteral drug manufacturing
- Evaluate manufacturing processes for contamination risks
- Lead or participate in complex sterility assurance projects
- Develop and execute facility monitoring strategies
- Conduct root cause analysis for major deviations
- Stay updated on regulatory requirements for sterility assurance
- Influence corporate guidance on sterility assurance
- Identify and implement continuous improvements
- Provide design input for new processes and facilities
- Represent sterility assurance programs during audits and inspections
- Assist in writing regulatory submissions
- Create and approve sterility assurance training materials
- Mentor less senior scientists within TS/MS
- Mentor less senior cross-functional personnel
- Provide technical consultation across the Parenteral Network
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Sonstige Vorteile
- Accommodation for individuals with disabilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly Deutschland GmbH 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 Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer im Gesundheitswesen mit Fokus auf die Entwicklung lebensverändernder Medikamente.
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