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Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Technical guidance for airflow pattern testing and aseptic process simulations in parenteral drug production. Degree in microbiology or related field and 5+ years in pharma manufacturing required. Excellent company pension plan.
Anforderungen
- Bachelor’s or Master’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- Understanding of scientific principles for manufacturing parenteral drug products
- 2+ years in pharmaceutical manufacturing
- 5+ years in pharmaceutical manufacturing
- Strong interpersonal skills for cross-functional teamwork
- Strong self-management and organizational skills
- Strong oral and written communication skills
- Experience with data analysis and trending
Aufgaben
- Ensure oversight of sterility assurance programs on the manufacturing floor
- Provide technical guidance for airflow pattern testing
- Support environmental monitoring performance qualifications
- Conduct aseptic process simulations
- Implement cleaning, sanitization, and disinfection strategies
- Oversee gowning procedures in GMP classified areas
- Apply aseptic processing techniques
- Develop contamination control strategies
- Assist in facility monitoring for effective contamination control
- Lead the development of the site's contamination control strategy
- Provide expertise for cleaning and sanitization programs
- Oversee the cleanroom gowning and aseptic technique strategy
- Author and oversee environmental monitoring performance qualifications
- Evaluate environmental monitoring data and create trend reports
- Identify facility environmental isolates and maintain cultures
- Author aseptic process simulation protocols and oversee execution
- Evaluate aseptic process simulation data and author reports
- Track aseptic process simulations to meet regulatory requirements
- Apply sterility assurance risk management to manufacturing processes
- Analyze microbial and manufacturing data for trends and improvements
- Support root cause investigations for sterility assurance programs
- Provide technical support during internal and external audits
- Create and review technical documents related to sterility assurance
- Collaborate with cross-functional teams to meet business objectives
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Noch nicht perfekt?
- 350 Lilly Deutschland GmbHVollzeitnur vor OrtSeniorAlzey
- Lilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
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Responsible Scientist – QC Microbiology Lab(m/w/x)
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Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Technical guidance for airflow pattern testing and aseptic process simulations in parenteral drug production. Degree in microbiology or related field and 5+ years in pharma manufacturing required. Excellent company pension plan.
Anforderungen
- Bachelor’s or Master’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- Understanding of scientific principles for manufacturing parenteral drug products
- 2+ years in pharmaceutical manufacturing
- 5+ years in pharmaceutical manufacturing
- Strong interpersonal skills for cross-functional teamwork
- Strong self-management and organizational skills
- Strong oral and written communication skills
- Experience with data analysis and trending
Aufgaben
- Ensure oversight of sterility assurance programs on the manufacturing floor
- Provide technical guidance for airflow pattern testing
- Support environmental monitoring performance qualifications
- Conduct aseptic process simulations
- Implement cleaning, sanitization, and disinfection strategies
- Oversee gowning procedures in GMP classified areas
- Apply aseptic processing techniques
- Develop contamination control strategies
- Assist in facility monitoring for effective contamination control
- Lead the development of the site's contamination control strategy
- Provide expertise for cleaning and sanitization programs
- Oversee the cleanroom gowning and aseptic technique strategy
- Author and oversee environmental monitoring performance qualifications
- Evaluate environmental monitoring data and create trend reports
- Identify facility environmental isolates and maintain cultures
- Author aseptic process simulation protocols and oversee execution
- Evaluate aseptic process simulation data and author reports
- Track aseptic process simulations to meet regulatory requirements
- Apply sterility assurance risk management to manufacturing processes
- Analyze microbial and manufacturing data for trends and improvements
- Support root cause investigations for sterility assurance programs
- Provide technical support during internal and external audits
- Create and review technical documents related to sterility assurance
- Collaborate with cross-functional teams to meet business objectives
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Über das Unternehmen
350 Lilly Deutschland GmbH
Branche
Healthcare
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
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Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Microbiologist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenAlzey - 350 Lilly Deutschland GmbH
Responsible Scientist – QC Microbiology Lab(m/w/x)
Vollzeitnur vor OrtSeniorAlzey, Wiesbaden - 350 Lilly Deutschland GmbH
Senior/Principal Scientist Validation(m/w/x)
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