Process Engineer

Vor 2 Tagen

Basel, Schweiz ITech Consult AG Vollzeit

Process Engineer / Plant Engineer (Process Engineering) (m/f/d) - GMP/ pharmaceutical production/ pharmaceutical production/ PC applications/ SAP/ MyBuy/ ELVIS/ COMOS/ German Project: For our pharmaceutical client based in Basel, we are looking for a Process Engineer / Operations Engineer (Process Engineering) (m/f/d) Background: In the Pharma Engineering Drug Substance Small Molecules division, we ensure the technical support and further development of the production facilities for manufacturing chemical active ingredients at the Roche site in Basel. We work in self-organized teams. This means a move away from rigid hierarchies towards a high degree of personal responsibility and collaborative coordination. Success in this position requires you to act proactively, structure your tasks independently, and actively contribute to the team. We are looking for individuals who think entrepreneurially and communicate decisions transparently. The position is initially vacant to temporarily strengthen our team and cover project peaks. If the collaboration is successful and there is a corresponding need, there is a clear possibility of long-term, external employment. The ideal candidate holds a degree in a technical or scientific field, particularly in process engineering, and has more than 5 years of experience in a GMP environment. Proficiency in standard PC applications and excellent written and spoken German skills are also essential. Main tasks and responsibilities P&ID Processing: Independent processing and maintenance of P&IDs in COMOS and ensuring data consistency Design Documentation (DQ): Creation of technical specifications (statements of work), data sheets and technical drawings as a basis for execution Isometry: Technical review and approval of isometrics and manufacturing documents for the pipeline construction companies Projektmanagement & Realisierung (Construction) Gewerke-Koordination: Steuerung und Koordination der unterschiedlichen Gewerke (Rohrleitungsbau, EMSR, Automation, Bau) für die Phasen Planung, Ausführung und Inbetriebnahme Bauleitung: Vor-Ort-Begleitung der Realisierung zur Sicherstellung der Montagequalität und Einhaltung der Sicherheitsvorschriften Ressourcensteuerung: Sicherstellung, dass Kleinprojekte unter Einhaltung des vereinbarten Umfangs, der Qualität, der Kosten und der Termine realisiert werden GMP-Compliance, Qualifizierung & Change Management Change Control: Definition und Festlegung aller erforderlichen Massnahmen (organisatorisch, technisch, dokumentarisch) zur erfolgreichen und regelkonformen Umsetzung einer Änderung Verifizierung (IQ/OQ): Erstellung der Abnahmeunterlagen (Testpläne, Protokolle) zur Verifizierung der Installationen sowie Begleitung der Abnahmen Dokumentation: Zusammenstellung der kompletten „As-Built #J-18808-Ljbffr

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