C&Q Engineer
As a successful C&Q Engineer you ensure that Commissioning and Qualification are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing commissioning and qualification for CAPEX- and OPEX-projects at CSL Behring.
In detail, your responsibilities include:
- Planning, coordination and execution of all phases for commissioning and qualification of GMP manufacturing systems according to local and global procedures and standards as well as legal requirements.
- Facilitating the development, performing review and approving technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Development of C&Q verification documents including but not limited to Commissioning/ Qualification plans, FMEA, IQ, OQ as well as for the execution of verification activities
- Coordination and oversight of vendor FAT/SAT, commissioning activities in collaboration with internal and external partners
- Planning and execution of PQ's including sterilization / depyrogenisation cycle development, Smoke Study, Temperature/Humidity mapping
- Assessing and handling of Change Controls, CAPAs and Non-Conformances related to qualification topics
- Work collaboratively with all stakeholders, Process Engineering, Project Delivery, Execution Systems, PALM Validation, PALM Stability, Value Streams, R&D, QC staff and others, to ensure that activities are planned and delivered in an efficient timeframe
- Provide support and management to the multi-site projects to deliver on the company key CapEx projects
Who you are:
- Master degree in a relevant science or engineering discipline
- Proven work experience in biotech or pharma company in an cGxP environment and/or C&Q equivalent position
- Experience and knowledge in sterilization / dehydrogenization is a plus
- Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
- Excellent written German and English
- Ability to communicate clearly and effectively
- Analytical thinking and problem-solving ability
- Self-time management
- Excellent team player
Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten.
CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring.
Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.
