Director Technical Services
Director Technical Services
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 three recombinant coagulation factors to treat hemophilia A & B patients. For one of these products we have already received marketing approval, for the second product we expect global market launch this year. 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 2019/2020.
Are you interested in being part of this exciting project?
We are looking for an experienced
Director Technical Services
- The Director Technical Services within Engineering Services will manage and coordinate Facility Management, Workshop (electrical and mechanical), Calibration and Maintenance Organization within Engineering Services
- The role will oversee all Maintenance activities (Operations, Utilities, Facility) within the Lengnau site
- Responsible for all questions relating to Maintenance, Facility Management, Waste Handling within the Lengnau project
- Active involvement issue resolution, commissioning and qualification activities and documentation preparation
Main Responsibilities and Accountabilities:
The main responsibilities for this position are:
- Lead and build up the commissioning and qualification execution team responsible for calibration during the project phase
Support and coordinate commissioning/balancing teams to ensure that the commissioning and qualification steps are achieved in line with the master schedule and support the startup of interdependent process areas
- Ensure that the Lengnau Facility design intent is reflected within quality-driven design deliverables and in accordance with the Project Brief, User Requirements, Local Authority conditions and Global Regulatory requirements
- Support the Project Team in the continuous improvement of the project management tools and processes, such as PM handbook, SOPs for the respective engineering business processes and components, which will assist the smooth running of project as well as acting as a report tool for the senior management
- Responsible and accountable for work according to cGxP requirements as laid out in the CSL SOPs and procedures as well as all relevant external / governmental guidance
Contribution to the delivery of the work according to health, safety and environmental requirements as laid out in the CSL SOPs and procedures as well as all relevant external / governmental guidance
- Active involvement in issue resolution, assisting cross-functional teams and attending coordination meetings between the various engineering disciplines leads to ensure smooth commissioning and qualification of the facility (building) as well as calibration
- Responsible and accountable for all project related discipline specific documents such as requirement specifications, design documents & deliverables and appropriate documents to support maintenance, calibration as well as Facility Management
- Responsible for ensuring that the systems are maintained in line with the CSL budget and master schedule
- Responsible for the setting up of the Engineering Maintenance Quality Management and Calibration System in collaboration with the Quality Engineering and Project Engineering departments
- Responsible for maintaining compliance with quality standards and all internal quality audit system
- Responsible for the setting up of the Facility Management department including cleaning and waste Management System within the Lengnau site
- Responsible for the setting up and implementation of the Plant Maintenance ERP System to cover all the maintenance and calibration activities as well as their planning and the management of the spare parts within the plant
Qualifications & Experience:
- Degree (Bachelor, Master or higher) in Engineering, Chemistry or Biochemistry, Dipl. Ing. or M.Sc. or B.Sc. or equivalent
- Strong operational experience preferably gained within the construction, maintenance & 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 engineering, chemical, biotech or pharmaceutical process and automation
- Proven experience in cGMP, GLP & cGxP and qualification/validation
- Proven experience in setting up of PM ERP System
- Languages: German and English fluent in writing and spoken preferred
Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?
Offices will be in Stöckacker, Bern, and later in Lengnau.
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. For initial information you are welcome to contact Recruitment at +41 31 344 12 51.
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