Engineering Project Manager for CSL Behring in Bern

We make it GmbH; Bern; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

CSL Behring AG in Bern sucht einen Engineering Project Manager, der verantwortlich ist für die Planung, Beschaffung, Bau und Qualifizierung neuer Anlagen zur Steigerung der Produktionskapazität. Sie führen interdisziplinäre Teams durch den gesamten Projektlebenszyklus und sichern Einhaltung von Meilensteinen, Budgets und regulatorischen Anforderungen.

Sie bringen ein abgeschlossenes Studium in Engineering, BWL oder Life Sciences mit sowie 10 Jahre Projekterfahrung in der Pharmaindustrie.

Qualifikationen

• Abgeschlossenes Studium in Engineering, BWL oder Life Sciences.
• 10 Jahre Erfahrung in der Leitung von Kapitalprojekten in der Pharmaindustrie.
• Idealerweise Erfahrung mit Annex 1 und Abfülllinien.
• Gf GMP-Kenntnisse und Herstellung in FDA-regulierten Einrichtungen.
• Fundierte Kenntnisse des Projektmanagements und der Lebenszyklusphasen; Validation, CMC, behördliche Einreichungen.
• Erfahrung im Umgang mit hohen Projektbudgets.
• Fähigkeit, mehrere Aufgaben gleichzeitig zu managen und funktionsübergreifend zu integrieren.
• Deutschkenntnisse sind Pflicht.

Aufgaben

• Verantwortlich für Aktivitäten zur Abdeckung, Entwicklung, Beschaffung, Bau und Qualifizierung neuer Anlagen und Einrichtungen.
• Leitung interdisziplinärer Teams durch den Projektlebenszyklus.
• Entwicklung und Pflege integrierter Projektpläne; Überwachung von Meilensteinen, Deliverables und Budget.
• Überwachung von Projektrisiken und Entwicklung von Risikominderungsstrategien.
• Sicherstellen, dass Initiativen mit Geschäftszielen übereinstimmen.
• Bereitstellung GMP-konformer Prozesse/Facilities für FDA- und globale Zulassungen.
• Implementierung von EHS-by-Design im Projekt.
• Regelmäßige Berichterstattung an Standortleitung und globale Lenkungsausschüsse.
• Teams sorgen für Abschluss der Lebenszyklusaktivitäten durch Qualifizierung.

Kenntnisse

German language

Projektleitung

Teamarbeit

Ausbildung

Engineering, Business Administration oder Life Sciences (MS/MBA/BS/BA oder äquivalent)

Tools

Trackwise

Veeva

Power BI/Clarity

Jobbeschreibung

We make it GmbH is a company operating nationally in Switzerland. Thanks to many years of successful experience, it has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it
GmbH places the highest demands on quality, ethics and discretion.

For our customer, the company CSL Behring, we are searching for:

Engineering Project Manager

Description

CSL Behring AG in Bern specializes in the manufacture of drugs for the treatment of immune deficiencies and immune dysfunction, as well as drugs for rhesus prophylaxis and albumin solutions for shock and burn victims. CSL Behring AG's production facilities are licensed by the Swiss health authorities and the US FDA. Every year, therapeutically important proteins are isolated from over six million liters of human plasma in accordance with the strictest safety and quality standards and processed into medicines. The products of CSL Behring AG are distributed worldwide.

CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

Working hours

Standard / 41 working hours

Aufgaben

• Responsible for project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet facility production throughput demands
• Leads multi-disciplinary Teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements
• Develops and maintains integrated project plans and monitors project activities for adherence to milestone timelines, deliverables and budget against approved plan
• Maintain oversight on project risks and develops risk mitigation strategies
• Ensures that initiatives are aligned with the business objectives and strategic philosophy
• Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval
• Responsible for implementing EHS by design principles in the project
• Responsible for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for site Sr. Management and Global Steering Committees
• Project Teams are responsible for completion of project lifecycle activities through performance qualification
• Influences teams to work collaboratively, to be customer focused and to deliver superior performance through personal leadership abilities, mentoring and effective communication

Qualifikation

• Successful studies in Engineering, Business Administration or Life Sciences (MS/MBA/BS/BA or equivalent)
• 10 years of experience in managing capital projects in the pharmaceutical industry
• Ideally experience of Annex 1 and filling lines
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
• Excellent understanding of project management principles and project lifecycle phases, including knowledge of Validation, CMC and facility regulatory submission requirements
• Experience to manage high level project budgets
• Ability to handle many tasks simultaneously and integrate project planning efforts across functions
• Ability to understand “the big picture” and approach problem solving in a proactive team manner
• German is mandatory
• Experience in Execution system
• Experience in Trackwise
• Experience in Veeva
• Power BI/Clarity.

Are you interested?

Then Mr. Raphael Sigg looks forward to receiving your complete

application documents (CV, certificates and training certificates). We look forward to hearing from you.