Automation Engineer Projects support

☞ Randstad Switzerland

View: 122

Update day: 25-03-2024

Location: Bern Bern BE

Category: IT - Software

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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Job content

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
Qualification
  • 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
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Deadline: 09-05-2024

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