vor 18 Tagen

Senior Manager - Logistic Equipment Engineering

1094 CSL Behring Rec. Fac. AG

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Senior Manager - Logistic Equipment Engineering

Senior Manager - Logistic Equipment Engineering

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

Senior Manager - Logistic Equipment Engineering

  • The position holder acts as Warehouse & Logistic Process Technology and Equipment Engineer
  • Reports to the Dir. Bulk Process Technology (Building Lead B&E)
  • The position holder is responsible that the requirements from QC and manufacturing regarding processes are the base for the engineering of the equipment, layout, rooms through Detailed Design, Construction, Commissioning, Qualification and Start Up within building E.
  • The position holder must coordinate closely with Bulk and Media&Buffer manufacturing personnel as well as area such as Clean Utilities Engineering personnel
  • The position holder contributes to the design of the maintenance system

Main Responsibilities and Accountabilities:

The main responsibilities for this position are:

  • Works on Process design (focused on logistics, high rack bay, storage rooms, raw material handling, etc.), inputting across the warehouse facility in accordance with the approved design, local codes and cGMP regulatory requirements
  • Interfaces with other project responsibles (Fill&Finish, USP/DSP/Media&Buffer, Utilities, Construction, etc.) in the project in order to assure overall coordination of the timelines and resources
  • Coordinates and coaches all equipment engineers within warehouse & logistic in regard of technical solutions, problem solving and interfaces
  • Liaises with customer groups on the project to ensure delivery according to user requirements, process best practices, in accordance with quality and safety requirements
  • Inputting to the group Engineering technology and interacts with the project team according to the project schedule and requirements as well as the needs of the future established Engineering Services organization
  • Ensures 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 & industry best practice
  • Support for the setting up of the new Quality management system, including SOPs for qualification and the Engineering and Project Management Organization
  • Support of the Maintenance Groups in the definition of the maintenance system and the maintenance schedule for building E
  • Responsible and accountable for working according to cGxP, health, safety and environmental requirements as laid out in the CSL SOPs and procedures as well as relevant external / governmental guidance
  • Contributing to the delivery of the company strategy as well as supporting the financial CapEx budgeting process for the engineering and Project Management Organization
  • Inputting for all projects (engineering) requirements specifications, requirement specifications etc. dealing with the logistics & warehouse process
  • Technical support for procurement, FAT & SAT of all process and logistics equipment
  • Interacts and coordinates the design/construction/commissioning/qualification teams for process technology and equipment within warehouse to ensure that the mechanical completion, commissioning and IQ/OQ/PQ steps are achieved in line with the master schedule and support the startup of interdependent functional areas
  • Active involvement in issue resolution, assisting cross-functional teams and attending coordination meetings between the various engineering disciplines leads to ensure smooth installation, construction and commissioning of the facility

Qualifications & Experience:

  • Degree (Bachelor, Master or higher) in mechanical, process or chemical engineering, Dipl. Ing. or M.Sc. or B.Sc. or equivalent
  • Strong leadership experience gained within the design, procurement, construction & qualification environment of a recombinant Biotech Upstream/Downstream manufacturing or Fill Finish facility
  • Several years of successful process technology support and leadership experience on mid-sized and major projects with high complexity in the chemical, biotech or pharmaceutical industry
  • Proven experience and knowledge in biotech, process and engineering
  • Proven experience in cGMP, GLP & cGxP and qualification
  • Languages: German and English fluent in writing and spoken

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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