Manager Monitoring

CSL Behring Lengnau AG (Lengnau BE, Schweiz) Vor 24 Tagen veröffentlicht

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete.  Today, more than 200 employees work in Lengnau.

You can find more information on the strategic partnership with Thermo Fisher here and some more information about the prospects of a future career with Thermo Fisher here.

We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards you help us to improve the quality of life for those in need.

We are currently recruiting for a

Manager Monitoring

Responsibilities:

  • Develop and maintain Best in class monitoring program including required procedure and monitoring/trending reports
  • Create procedures, working instruction, protocols/report templates related to Environmental Monitoring (EM) and Clean Utilities (CU) qualifications
  • Act as System Mater Expert in project phase to ensure adequate design of equipment and systems
  • Drive the creation of Risk Assessments for definition of qualification and routine monitoring sampling points for EM and CU
  • Support qualification team for protocols and reports establishment  and provide technical support/training on validation and regulatory requirements
  • Manage deviation resolution arising from validation activities and routine monitoring in cooperation with key partners
  • Support the implementation of Laboratory Instrument Management System (LIMS) and other IT tool required for qualification and routine Monitoring
  • Write monitoring and trending reports in collaboration with stakeholder.
  • Communicates cross functionally regarding needs and status of assigned study activities
  • Manage contractors and/or internal staff to achieve project deliverables;
  • Ensure regulatory inspections by presenting qualification procedures, strategies and all related monitoring documents.



Qualifications:

  • Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
  • 6+ years' quality systems/validation experience in pharmaceutical manufacturing/an highly regulated industry, with proven experience of clean Utilities/ rooms monitoring program management
  • Knowledge of current Good Manufacturing Practices (cGMP),  Health authority requirements (e.g. FDA,  EMA)
  • Knowledge of industry standards of Rooms and Clean Utilities qualification and monitoring
  • Proven experience in Quality Systems like Change control, deviation including investigation, CAPA implementation.
  • Experience required Laboratory Instrument Management System (LIMS) and statistical background is a plus

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

Worker Type:

Employee

Worker Sub Type:

Regular
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