Position: Mid-Senior level

Job type: Full-time

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Job content

Summary

Provides support of the MES project. Participate to the creation of the MES MBR in an efficient and proactive way. Has personal accountability and responsibility for coordinating all the different activities in the MBR creation.

Duties and Responsibilities
  • Work with the MES team and the supplier (Werum) on the detailed design deliverables concerning MBR.
  • Draft, Review, code, test and approve the relevant design documentation (Specifications, MBR, …).
  • Support the implementation on site with MFG the MBR.
  • Support the process of continuous improvement for the MES solution and the MBRs.
  • Support the MES testing activities (test execution or test witnessing).
  • Support the MBR/system/interfaces trouble shooting using Incyte quality systems.
  • Support the implement of new interfaces.
  • Participate to SOPs elaboration/correction/improvement (User SOPs. Admin SOPs …).
  • Train the users.
  • Participate to the On Call service.
  • Act as system owner backup if required.
  • At all times work in view of the site readiness for regulatory inspections (Swissmedic and International).
  • Contribute positively to a strong culture of business integrity and ethics.
  • Act within compliance and legal requirements as well as within company guidelines.
Requirements
  • Must have minimum of 5 years in an MBR creator/MES Admin role in a biopharmaceutical manufacturing environment.
  • Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Automation or engineering.
  • Advanced degree preferred.
  • Strong experience of MES systems (validation and operational activities).
  • Must speak English and French.
  • Thorough knowledge of biotechnological technologies, processes, with a demonstrated experience in computerized and automated systems (MES, Werum PAS-X is a plus).
  • Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation.
  • Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems.
  • The ability to make pragmatic and compliant decisions.
  • Strong result orientation and committed team member.
  • Flexibility and ability to travel.
  • Excellent written and verbal communication skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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Deadline: 08-06-2024

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