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Lead Qualification Compliance (m/f/d) 100%

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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.

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. The CSL Behring Lengnau AG is part of CSL’s ongoing global expansion strategy to support the company’s long-term growth plans.

The new plant in Lengnau with its highly advanced facilities will manufacture innovative and promising therapeutics with the aim to enhance the quality of the patient’s lives. One of the main products will be a recombinant coagulation factor to treat hemophilia B patients.

Are you interested in being part of this exciting project?

To start in January 2020 in Lengnau, we are looking for an experienced

Lead Qualification Compliance (m/f/d) 100%

This position requires experience in commissioning/qualification activities in the GMP environment of Life Sciences / Pharma / Biotech Upstream/Downstream or Fill Finish manufacturing facilities. The candidate should have a good experience of all project phases, including design, construction, C&Q and operational readiness. During the period of establishing the new manufacturing site the position holder will be part of the facility program and coordinate as well oversee commissioning and qualification activities as QA representative in the program matrix structure. First experience or interest in personnel management is also required.

Main Responsibilities and Accountabilities:

  • Responsible as QA representative in a multidisciplinary team to oversee and review/approve Qualification Design and Verification documents throughout the project phase as well as within routine operations.
  • Ensure that the Quality by Design (QbD) principles are integrated into elements leading to qualification activities.
  • Support our Engineers and Manufacturing Experts in the Design of facilities, utilities and equipment to ensure compliance from QA perspective is in the current project phase as much as important as the supporting QA function of the position holder after installation and qualification during routine operations.
  • Develop and improve state of the art Commissioning and Qualification (C&Q) concepts and their applications in the C&Q project phase within a highly motivated and engaged project team will be a major task.
  • Participate in the preparation and attendance to health authority inspections within their area of responsibilities.

Qualifications & Experience:

  • MS/MBA/BS/BA in Life Sciences (e.g. Biology, Chemistry) or Engineering
  • Experiance in Qualification required, preferably gained on a Life Sciences / Pharma / Biotech / Fill Finish manufacturing facility
  • At least 5 years of successful commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech-or pharmaceutical industry necessary
  • Proven experience and knowledge in chemical, biotech or pharmaceutical process, automation and engineering
  • Proven experience in an GxP environment
  • Language: Good command of German as well as English (written and spoken)
  • Ability to work well both independently and in a team environment to ensure successful outcomes
  • Ability to handle changing priorities and multiple tasks across functions
  • Ability to understand “the big picture” and approach problem solving in a proactive manner
  • Motivated and engaged to experience and professionally handle “out of routine challenges”
  • Leadership capabilities

Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?

We are looking forward to receiving your online application: https://csl.recsolu.com/jobs/UohQ-vgQOCv0l6jllLoBCw?locale=de. 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.

Adresse

CSL Behring Lengnau AG
Frau Maria Guseva
Talent Acquisition Consultant

Website https://csl.recsolu.com/jobs/UohQ-vgQOCv0l6jllLoBCw?locale=de

Bern / Lengnau / Marburg (Germany) or Bern (Switzerland) / Marburg (DE) oder Bern (CH) / Lengnau BE / Bern CH, Broadmedows AUS, Kankakee US, Marburg D / Bern CH, Marburg DE, Broadmeadows AUS, Kankakee US

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