Posted to MedZilla on 8/19/2017


ProClinical

Switzerland, Director, Building Lead Facility Project RCF QA_AL_13102-MZ


 
 

ProClinical is working with an innovative, global project management and engineering company who is seeking a  Building Lead Facility Project Director. This role is a contract position based in Biel, Switzerland.

Job Responsibilities:

  • Responsible for leading and managing the subproject for building x of LGN RCF project:
  • Responsible and accountable for leading the building and process design for building X in accordance with the approved design, local codes and cGMP regulatory requirements
  • Lead and manage process technology input into equipment URS s, specifications & technical support to procurement.
  • Provide technical support to the AE Design effort on the full Bulk project scope.
  • Ensure the execution of the design review processes including all necessary & appropriate design reviews, 3-D Model reviews, stage-gate processes, cGMP Reviews, Hazop Reviews etc.
  • Coordination with all specialists providing input into design & review of documents & drawings to ensure execution in a timely manner to support the design schedule.
  • 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.
  • Contributing 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. 
  • Lead, manage and coordinate the construction/ commissioning/qualification teams for building X including process technology and equipment to ensure that the mechanical completion, commissioning and IQ/OQ/PQ steps are achieved in line with the master schedule and support the start-up of interdependent functional areas.
  • Ensure technical support for procurement, FAT & SAT of all facility and process equipment & skids.
  • Ensure technical support for day to day construction activities for building X and of vendors on installation of equipment and modules
  • 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.

Skills and Requirements:

  • University degree in engineering/technical/scientific discipline
  • Excellent analytical skills; organizational and project management skills; attention to detail, the ability to work well under pressure; competence in documentation practices (including IT skills)
  • Excellent people management skills and experience
  • Good interpersonal and team contribution skills at all levels
  • Oral, written and interpersonal communication skills (in English), German language is a plus
  • 10+ years’ experience in the biopharmaceutical industry and demonstrated experience within multi-functional portfolio/project management or equivalent
  • Proven track record of managing large CAPEX projects
  • The ability to clearly monitor and control project and program progress.
  • Proficiency and use of enterprise computer applications including the Microsoft suite of products and project management software and tools.
  • Excellent skills in team building and interpersonal skills across cultures.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Amber Lakeman on +44 20 3690 593 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.