Lonza
Process Expert – Cleaning (m/w/x)
Vollzeitnur vor OrtBerufserfahren
Stein (AR)
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
Nejo KI-Zusammenfassung
Shaping Contamination Control Strategy for aseptic Drug Product manufacturing, leading APS/Media Fills and Smoke Studies. Expertise in sterile processing and cleanroom classifications required. Relocation assistance, lifestyle and family benefits.
Deine Match-Analyse
von deinem Karriere-Agenten
Warum dieser Job zu dir passt
Mögliche Lücken
Tipps für deine Bewerbung
Anforderungen
- Hands-on experience in aseptic Drug Product manufacturing
- Fill & Finish operations for vials and/or syringes
- Strong understanding of sterile processing principles
- Expertise in Cleaning Validation or Contamination Control Strategy (CCS)
- Solid understanding of cleanroom classifications
- Solid understanding of material flows
- Solid understanding of HVAC concepts
- Solid understanding of contamination control principles
- Ability to perform and document risk-based assessments
- Degree in Engineering, Life Sciences, Pharmaceutical Sciences or related discipline
- Fluent English communication skills
- Ability to collaborate effectively across diverse stakeholders
- Agile, proactive and solutions-oriented mindset
- Ability to thrive in a fast-paced, dynamic environment
- Ability to drive alignment across multiple functions
- Experience supporting regulatory inspections is a plus
- Experience supporting health authority interactions is a plus
Aufgaben
- Shape and drive the Contamination Control Strategy (CCS)
- Lead key initiatives such as APS/Media Fills, EMPQ, and Smoke Studies
- Lead associated risk assessments for inspection readiness
- Provide strategic technical expertise for contamination control programs
- Support implementation of contamination control programs
- Support maintenance of contamination control programs
- Support continuous improvement of contamination control programs
- Ensure regulatory compliance for manufacturing performance
- Act as Subject Matter Expert for Sterility Assurance
- Act as Subject Matter Expert for Contamination Control
- Act as Subject Matter Expert for Cleaning Validation
- Provide strategic technical leadership for sterile manufacturing operations
- Support compliant sterile manufacturing operations
- Support efficient sterile manufacturing operations
- Support inspection-ready sterile manufacturing operations
- Drive risk assessments for the Contamination Control Strategy
- Drive cross-contamination prevention measures
- Drive robust contamination control programs across the site
- Support the lifecycle strategy of sterility assurance programs
- Support the execution of sterility assurance programs
- Support Aseptic Process Simulations (APS/Media Fills)
- Support Environmental Monitoring Performance Qualification (EM PQ)
- Support Smoke Studies
- Support EMPQ and associated validation activities
- Develop Cleaning Validation protocols
- Optimize Cleaning Validation protocols
- Sustain Cleaning Validation programs
- Close compliance gaps in cleaning validation
- Strengthen process robustness in cleaning validation
- Ensure effective validation of equipment
- Ensure effective validation of facilities
- Ensure effective validation of manufacturing processes
- Drive complex investigations
- Drive deviations
- Drive CAPAs
- Drive continuous improvement initiatives
- Partner across functions to support facility start-up
- Partner across functions to support project delivery
- Partner across functions to support regulatory inspections
Berufserfahrung
ca. 1 - 4 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – fließend
Benefits
Boni & Prämien
- Compensation programs for high performance
Mitarbeiterrabatte
- Lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work culture
- Inclusive workplace
Sinnstiftende Arbeit
- Ethical workplace
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza 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.
Zur Originalanzeige bei LonzaÜber das Unternehmen
LO
PharmaceuticalsStein (AR)
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Wie gut ist dein Lebenslauf?
Nejo bewertet ihn, und bringt ihn danach gemeinsam mit dir in Bestform.
Du hast noch keinen Lebenslauf?
Noch nicht perfekt?
- LonzaProcess Expert - Compounding & Support (m/w/x)Vollzeitnur vor OrtBerufserfahrenStein (AR)
- LonzaSenior Global Technology Transfer Lead (m/w/x)Vollzeitnur vor OrtSeniorStein (AR)
- LonzaMaintenance Excellence Expert (m/w/x)Vollzeitnur vor OrtBerufserfahrenStein (AR)
- LonzaTechnology Transfer Lead (m/w/x)Vollzeitnur vor OrtSeniorStein (AR)