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 Recombinant Facility (RCF) in Lengnau is part of CSL's ongoing global expansion strategy to support the company's long-term growth plans.
The new plant in Lengnau will manufacture recombinant coagulation factors to treat hemophilia A & B patients. The Lengnau site project generates an investment of several hundred millions USD and will create around 300 new jobs when it is fully operational in 2020.
Are you interested in being part of this exciting project?
We are looking for an experienced
Senior Manager, Project Quality (F/M)
In this role, you will be supporting the Lengnau Facility Project Team's ambitions of delivering a 'Right First Time' project to manufacturing operations.
Main Responsibilities and Accountabilities:
Managing the Lengnau Facility Project Engineering Quality Management system to ensure Quality is proactively engineered into, and assured on the project by design engineers, vendors, contractors and constructors.
Developing Project Quality Management plans, Audit processes and schedules and document review processes to assure the use of Good Engineering Practices and Good Documentation Practices and trains the project community in the same.
Leads the Engineering Quality Assurance and Document Management teams.
Strengthens collaboration with all project team functions and members.
Proactively identifies resource requirements and builds teams using both CSL and external resources.
Qualifications and Experience:
University degree (Uni, ETH, FH, Bachelor or Master) in Engineering, Chemistry or Biochemistry or equivalent.
Strong operational experience preferably gained within the construction & qualification environment ideally on a Life Sciences / Pharma / Biotech Upstream/Downstream/Fill Finish manufacturing facility.
Several years of successful design/construction/commissioning/operational experience on mid-sized and major projects with high complexity in the chemical, biotech- or pharmaceutical industry.
Proven experience and knowledge in chemical, biotech or pharmaceutical process, automation and engineering.
Proven experience in cGMP, GLP & cGxP and qualification/validation.
Are you interested? 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.
Offices will be in Lengnau.
CSL Behring is committed to provide equal employment opportunity for all.