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Open nowPosted 23 days ago

Senior Automation Engineer PCS/MES

job-room.ch86,007 open roles

Where
Berne, BE, Switzerland
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Your applicationOpen nowSenior Automation Engineer PCS/MESjob-room.ch · Berne, BE, Switzerland

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  3. 7.9%7 days
  4. 14.2%14 days
  5. 34.1%30 days
This job: posted 23 days ago

The posting

Im Bereich Automation Engineering am Standort Bern, suchen wirfür denValue Stream Filling, aktuell einen   

Senior Automation Engineer PCS/MES-Filling(m/w/d)   

Als erfolgreicher Senior Automation Engineer stellen Sie die zuverlässige Produktion in unseren aseptischen und GMP-regulierten Abfüllanlagen sicher. Gemeinsam mit Ihren Teamkollegen sind Sie verantwortlich für den Betrieb, die Weiterentwicklung und den Lifecycle-Support der Automatisierungs- und Manufacturing Execution Systeme (MES) im Bereich Filling.   

Nebst der Realisierung von Investitionsprojekten koordinieren und implementieren Sie Änderungen zur Prozessoptimierung, Compliance-Sicherung und Störungsbehebung an komplexen Produktionssystemen. Dabei arbeiten Sie eng mit Produktion, Manufacturing, Quality, CSV, Engineering, IT sowie externen Partnern zusammen.   

Zu Ihren Aufgaben gehören: 

* Führende Rolle in Automatisierungs- und MES-Projekten als Teilprojektleiter Automation/MES 

* Spezifikation, Implementierung, Inbetriebnahme, Qualifizierung und Lifecycle-Support von PCS 7-, SIMATIC Batch- und Opcenter-Systemen 

* Erstellung, Pflege und Optimierung elektronischer Herstellrezepte (MBRs) und Batchprozesse gemäss ISA-S88 und ISA-S95 

* Konfiguration und Weiterentwicklung von Siemens Opcenter Execution Pharma (MES) inklusive Schnittstellen zu SAP, LIMS, Data Historian und Package Unit Systemen 

* Analyse und Behebung komplexer Produktionsstörungen sowie Durchführung von Ursachenanalysen 

* Unterstützung von GMP-relevanten Aktivitäten wie CAPAs, Deviations, Change Controls und Inspektionen 

* Erstellung und Review von GMP-Dokumentation, Spezifikationen, Risikoanalysen, Test- und Qualifizierungsdokumenten 

* Unterstützung von FAT, SAT, Commissioning, IQ/OQ/PQ und CSV-Aktivitäten 

* Sicherstellung eines zuverlässigen Betriebs der Produktions- und Automatisierungssysteme 

* Umsetzung von Prozessverbesserungen und Digitalisierungsinitiativen zur Steigerung von Effizienz, Qualität und Anlagenverfügbarkeit 

* Betreuung und Steuerung externer Integratoren und Lieferanten.  

Das bringen Sie mit:

* Bachelor- oder Masterabschluss in Automation, Elektrotechnik, Informatik, Verfahrenstechnik oder vergleichbare Qualifikation 

* Mindestens 5 Jahre Berufserfahrung im Bereich Automatisierung und MES in einem GMP-regulierten Umfeld, vorzugsweise in der pharmazeutischen Industrie 

* Fundierte Kenntnisse in Siemens PCS 7 und Batch 

* Fundierte Kenntnisse in Siemens Opcenter Execution Pharma 

* Erfahrung mit pharmazeutischen Herstellprozessen, idealerweise im Bereich der aseptischen Abfüllung 

* Sehr gute Kenntnisse der GMP-Anforderungen sowie Erfahrung mit CSV, Data Integrity, Annex 11 und GAMP 5 

* Kenntnisse der Standards ISA-S88 und ISA-S95 

* Erfahrung in der technischen Führung von Projekten sowie in der Zusammenarbeit mit interdisziplinären Teams 

* Ausgeprägte analytische Fähigkeiten sowie strukturierte und selbständige Arbeitsweise 

* Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift runden ihr Profil 

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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