Equipment Specialist
Vor 2 Tagen
Job Description Summary
Ausführung der zugewiesenen Aufgaben und Tätigkeiten in der biopharmazeutischen Produktion unter Einhaltung der relevanten GMP-, Arbeitssicherheits- und Umweltrichtlinien.
Operative Routinetätigkeiten um den Herstellprozess fachgerecht durchzuführen und die zeitgerechte Bereitstellung von Wirkstoff in korrekter Qualität und Quantität zu ermöglichen.
Job Description
- Mitarbeit im biopharmazeutischen Herstellungsprozess.
- Ausführung aller zugewiesenen Tätigkeiten unter Einhaltung der gültigen GMP-, Arbeits-, Betriebs-, Umwelt- und Sicherheitsanweisungen und –richtlinien.
- Anleitung von neuen Mitarbeitern während des on-the-job Trainings / Einarbeitungszeit.
- Verantwortliche Durchführung einzelner Prozessstufen (Vorbereitung, Durchführung, Abschluss).
- Ordnungsgemäße und zeitgerechte Reinigung, Vorbereitung und Sterilisierung der Produktionsgeräte und Produktionsräume.
- Durchführung von zugewiesenen Produktionsservicetätigkeiten (z.B. SAP-Buchungen, Dokumentenvorbereitung und –prüfung, Unterstützung bei Wartungsarbeiten).
- Probenzug, Aliquotierung, Verteilung und Durchführung von ln-Prozesskontrollen.
- Durchführung des delegierten Umgebungsmonitorings für Reinräume und der delegierten Bemusterung von Reinstwasser und Reindampf.
- Organisation von Sofortmaßnahmen im Störungsfall, Melden von Auffälligkeiten an den Vorgesetzten.
- Exzellente Dokumentation der Tätigkeiten gemäß GMP-Vorschriften.
- Einsatz für kontinuierliche Verbesserung.
- Ordnungsgemäßer Umgang mit biologischen und chemischen Substanzen in der Produktionsanlage.
- Bereitschaft zur kontinuierlichen Verbesserung und Schwachstellenanalyse.
- Teilnahme an allen für die Stelle relevanten Schulungen, Pflege der entsprechenden Trainingsnachweise.
- Voranbringen und Erhaltung eines HSE gerechten Umfelds: Melden von Beinahe-Unfällen.
- Zeitweise Einsätze am Wochenende/Feiertagen und Bereitschaftsdienst nach Plan wenn erforderlich.
Skills Desired
- Good Documentation Practice
- Knowledge of GMP
- Lean Manufacturing
- Manufacturing Process
- General HSE Knowledge
- Cooperation
- Flexibility
- Efficiency
- Biological and Chemical Substance Handling
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