Responsible Engineer Calibration - Instrumentation & Control

Details

  • Category: Biotechnology
  • Location: Northwestern Switzerland
  • Starting date: Nov 01, 2018
  • Domain of experience: Calibration
  • Level required: Experts & Senior
  • Years of experience: 5-7

Your Role

The Responsible Engineer (RE) Calibration works in close collaboration with Quality, Automation, and I&C Technicians to design, specify and install calibration processes for Manufacturing, as well as to provide engineering support for all utilities, process and lab equipment for the new Manufacturing Site.

Your Tasks

  • Processing I&C troubleshooting and investigations for both GMP and Non-GMP manufacturing instrumentation systems
  • Configuring Instrumentation & Control systems including utilities, process & laboratory instrumentation, control system hardware, and related software (Delta V, DCS, SCADA, DAS, “Smart” Instrumentation and PLC systems)
  • Authoring deviations, CAPA’s and/or change control records in a GMP environment as well as updating instrumentation & control panel drawings
  • Designing, specifying, overseeing implementation and testing activities of new manufacturing process instrumentation
  • Providing project support and/or project management for capital projects and global initiatives to implement new facilities, equipment, and instrumentation
  • Identifying needed enhancements and leading projects related to instrumentation, hardware and software upgrades utilized on process and utility systems (including interim supervision of I&C technicians and support of FAT activities)
  • Training Calibration Technicians and managing small to medium engineering projects
  • Working directly with Contractors
  • Implementing changes and improving on existing processes
  • Overseeing lifecycle management for instrumentation systems and equipment
  • Supporting validation, quality, regulatory and safety activities to ensure compliance with policies and procedure

Your Profile

 
  • Engineering Degree in Automation, Electronic, Calibration or Mechanical Engineering
  • First experience on mid-sized and major projects for Instrumentation with high complexity in the chemical, biotech or pharmaceutical industry
  • Several years of successful project management experience on mid-sized and major projects for Instrumentation with high complexity in the chemical, biotech or pharmaceutical industry
  • Expert in CRA processes (Critical Risk Analysis)
  • Excellent communication skills (written and spoken) in English
  • Team player, able to shift priorities and willing to take part in a startup project
  • Solution-oriented, at ease within a complex international environment
 
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