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About Us

GXP CONSULTING Switzerland is a company specialized in Life Sciences which provides high quality support to its customers all along the product lifecycle.

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Global Automation Program Manager for multisite program (H/F)

Global Automation Program Manager for multisite program

 

Position Purpose

  • To ensure and coordinate agreed Global Automation deliverables of multi-site projects across the three project sites is delivered and implemented successfully.
  • To ensure that the three sites remain as aligned as practical from an automation perspective and to highlight and harmonize hardware, software and process related differences between the sites.
  • To ensure and coordinate Siemens global contract scope and project execution strategy (PES) is delivered successfully.
  • To ensure that the projects linked to the program are respecting the plan in term of schedule and cost, and that the related sequences are organized in the most effective way during the different phases of the project execution.
  • Engagement term.
  • Full time until mid-2019 then potentially reduced to 3 days / week until end 2019, depending on requirements.
  • Reporting.
  • Member of the Global Engineering Department. Reports to the Director Global Automation Lead.

Main Responsibilities and accountabilities

  • Aligning contracts (across sites) and management of Global Automation supply by Siemens.
  • Ensure Siemens delivery to schedule for all common supply.
  • Act as point of contact for Siemens Global PM.
  • Develop a schedule of agreed global deliverables.
  • Technical alignment across the three projects.
  • Deliver all global documentation for the program.
  • Participate to the GBF automation steering committee.
  • Global QPP.
  • Ensure Instrumentation harmonisation and calibration alignment for GBF program.
  • Challenge and enforce Siemens project execution strategy (PES) across the projects.
  • Manage the change process for global automation elements including harmonised software library.
  • Develop multi-site life cycle plan (post qualification) for the global software library in collaboration with the three sites.
  • Work collaboratively with all GBF Automation PM's to and Automation site heads on all common global aspects of program.
  • Cross site data exchange capability and alignment across sites for GBF program.
  • Infrastructure alignment for GBF program (Key BT interface – Infrastructure Platform).
  • Qualification alignment for GBF Automation following the global ICQ approach.
  • Alignment of automation delivery of package units (Filter press, centrifuge, etc).
  • Develop appropriate KPIs to monitor and report the progress of the Automation.
  • Harmonisation of Electronic Batch Report across the program.

Experience Required

  • Siemens PCS 7
  • Pharmaceutical regulations, GMP
  • Major capital project delivery.
  • Good knowledge of interaction with process and Automation systems.
  • English required, German language skills would be an advantage.
  • Good knowledge of GAMP last revision (Good Automation Manufacturing Practices currently at version 5) and related implementation.
  • Deep knowledge of S88.01 and S95 standards. Modular and object oriented coding structure and batch systems.
  • Good knowledge of 21 CFR part 11 requirements and related implementation
  • Knowledge of Werum Manufacturing Execution Systems.
  • Risk assessment and mitigation measures.
  • Data management and related data security implementation.

 

GXP  CONSULTING  Switzerland  is  specialized  in  Life  Sciences  and  provides  high  quality  support and expertise to its customers through a full range of services all along the product lifecycle. Thanks to our extensive experiences, we offer pragmatic solutions in areas such as Quality Assurance, Regulatory Affairs, Operational Excellence, Engineering, Process Engineering, Manufacturing and Maintenance, Project Management, Human Factors/Usability and trainings... If  you  have  exceptional  technical  skills,  a  great  personality and  you  are  passionate  about  serving others, then GXP CONSULTING Switzerland is the right place for you.
Manager, Automation
Qualified candidates must be legally eligible to work for any employer in Switzerland.
We do not accept unsolicited resumes from recruiters/third parties.  
Please submit your application to: p.debrabandere@gxp-cs.com

GXP Consulting Services

    Job Information

  • CompanyGXP CONSULTING Switzerland Sàrl
  • LocationLausanne 1003, Vaud Suisse
  • Job TypeTemps plein
    CDI
  • Job CategoryGestion de projet / programme
  • N° de réf.11.01.2018/FR
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1003 Lausanne
Switzerland
PO BOX 8009

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