automation engineer projects support in Bern

Moutusi Chattopadhyay, Zurich IT Professionals
job type
apply now

job details

life sciences
job type
reference number
moutusi chattopadhyay, zurich it professionals
058 201 56 67

job description

               Automation Engineer  Projects support


We are looking for a Automation engineer Project support who is having pharma or medical device experience for one of our globally renowned clients in the field of Pharma and Medical device

  • Assist the Senior Engineer in CAPEX projects: under his general supervision, this position will perform and assist technical work, provide engineering and design services, and/or develops concepts, designs and details.
  • Preparation, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment) focus on, but not limited to, CSV for new systems in collaboration with internal and external partner
  •  Support for Change Control creation and tracking of defined action items
  • Contribution to ensure that changes to systems, procedures, processes and formulas are appropriately managed such that resulting impact on equipment / computerized systems commissioning and qualification process are assessed and resolved.
  •  Compilation of costs for CAPEX application (supplier quotations, and internal workload    estimation)
  • Management of all orders related to a project (delivery, delays, receipt, feedback)
  •  Organization of meetings and status reporting  
  •  Bachelor/Master’s degree in technical or natural sciences
  •  A minimum of 3 years of working experience
  •  Experience in the pharmaceutical industry and GMP
  •  Know-how of CSV requirements according to FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines
  •  Technical understanding of the function of equipment and understanding of the offers and needs of the departments (Qualification, Engineering, Production)
  •  Sound experience with various IT-tools, systems, especially MS
  •  Excellent communication skills
  •  Business fluency in German and English
  •  Understanding of automation related topics is a plus
  •  Understanding of finance and cost control is a plus
  •  Quick learning ability and shown hands-on mentality
Dont hesitate to apply. Good luck