350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Full-timeOn-siteSenior
Alzey
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LILilly Deutschland GmbH
Sterility Assurance Advisor – Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Leading sterility assurance for parenteral products, optimizing process control strategies. In-depth knowledge of GMPs and microbiology required. Accommodation for individuals with disabilities.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Other Benefits
- Accommodation for individuals with disabilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lilly Deutschland GmbH 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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LILilly Deutschland GmbH
Sterility Assurance Advisor – Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Leading sterility assurance for parenteral products, optimizing process control strategies. In-depth knowledge of GMPs and microbiology required. Accommodation for individuals with disabilities.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Other Benefits
- Accommodation for individuals with disabilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lilly Deutschland GmbH 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
Lilly Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer im Gesundheitswesen mit Fokus auf die Entwicklung lebensverändernder Medikamente.
Not a perfect match?
- 350 Lilly Deutschland GmbH
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