Fraser Dove International are seeking a Senior Process Engineer/Manager to help develop a state-of-the-art biotech manufacturing facility in Switzerland.

A subject matter expert in production processes such as USP, DSP and Media Buffer preparation, you will be tasked with ensuring that all electronic processes in the manufacturing facility are specified and designed in an integrated, efficient manner to minimise cost and maximise output without maintaining quality and safety. Where required, you will also lend your expertise to the troubleshooting of equipment/automation issues as they arise as well as managing Value Stream mapping, including related KPIs.

Responsibilities:

This individual’s main objectives in order of priority are as follows:

  • Create, configure and develop electronic manufacturing processes (Drug Substance, Fill/Finishing, Shared Services, Plant Logistics).
  • Develop and perform experimental process tests/qualifications with respect to efficiency, method, quality, etc.
  • Create and manage process documentation and operating instructions.
  • Define, measure and analyze electronic processes.
  • Execute electronic processes PCS, MES.
  • Ensure innovation and continuous improvement.
  • Support Project phase and Operations.
  • Ensure cGMP requirements for electronic manufacturing processes.

Requirements

You will possess the following skills and attributes:

  • University degree (Bachelor or Master) in Computer Systems, Chemical, Mechanical, Electrical Engineering or Information Technology.
  • Minimum 8-10 years working experience in a manufacturing environment with Information and/or Automation Technology systems.
  • Experience with the following platforms is desired: OSI-PI, Siemens PCS7, Siemens MES, SQL.
  • Experience with data analysis or data mining.
  • Experience with GAMP5 and FDA CFR 21 part 11.
  • Knowledge of Lean six Sigma.
Please Note:
  • All preselected Applications will be forwarded and processed by our Swiss Partner, SDE Services AG, according to Swiss law.
  • This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

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