![BI Pharma GmbH&Co.KG](https://media.trabajo.org/img/noimg.jpg)
(Professional) Validation Engineeer
vor 3 Wochen
**Die Stelle**:
Verfügen Sie über fundierte Kenntnisse in der Reinmedientechnik oder Qualifizierung im GMP-Umfeld? Dann sollten wir uns kennenlernen.
Der Bereich „Critical Utilities Germany“ konzipiert, errichtet und betreibt die Reinmediensysteme des Global Facility Engineering an den deutschen Produktions
- und Entwicklungsstandorten von Boehringer Ingelheim.
Für das Team „Critical Utilities Engineering“ am Standort Biberach an der Riss suchen wir Sie als Qualifizierungs Ingenieur*in Reinmedien/ Critical Utilities
Diese Stelle ist mit 80 Prozent teilzeitfähig. Es sind zwei neu geschaffene Stellen zu besetzen.
***Aufgaben und Zuständigkeiten**:
- In Ihrer neuen Rolle erstellen Sie Validierungs-/Qualifizierungsdokumente für Reinmediensysteme zur Versorgung verschiedener Produktions
- und Entwicklungsbereiche mit deren Automatisierung (Gereinigtes Wasser, Gase, WFI, Reinstdampf, CIP/SIP)- Dazu gehört neben der eigenverantwortlichen Organisation und Durchführung der Validierungs-/Qualifizierungsaktivitäten die Abstimmung mit Schnittstellen wie z.B. Quality
- und Compliancefunktionen sowie technischen Einheiten.- Als Validation Manager verantworten Sie die Aufrechterhaltung des validierten Zustands der Reinmediensysteme. Dazu gehören neben Management technischer Change Controls die Unterstützung bei Untersuchungen zu Qualitätsereignissen oder Fehleranalysen.- Sie leisten einen aktiven Beitrag bei der kontinuierlichen Verbesserung von Prozessen und Vorgaben durch Einbringen von Vorschlägen und Anpassung der jeweiligen Dokumente.- Zudem vertreten Sie Ihren Bereich kompetent bei internationalen cGMP-Audits und Inspektionen.- Sie Führen von Engineering
- oder Qualifizierungsprojekte bei Neu
- oder Umbau von Reinmediensystemen.
***Anforderungen**:
- Studienabschluss Diplom/Master Fachrichtung Pharmatechnologie, Versorgungs-/ Verfahrenstechnik oder vergleichbarer technischer Disziplinen- Erfahrung im Planen, Errichten und Betreiben oder im Bereich Validierung/Qualifizierung versorgungstechnischer Systeme im Pharma-Umfeld- Sehr gute Kenntnis der relevanten cGMP Regelwerke und Good Engineering Practice (GEP) der Anlagenqualifizierung und Computersystemvalidierung- Vorausschauende und strukturierte, zielorientierte Arbeitsweise. Eigeninitiative sowie ein hohes Maß an Teamfähigkeit- Fließende Deutsch
- und Englischkenntnisse
***Sie wollen mit uns in Kontakt treten?**:
Bitte wenden Sie sich an unser HR Direct Team, Tel.: +49 (0) 6132 77-3330.
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