MBR Design Engineer

Overview

AsEngineer MBRDesign, you will ensure the configuration and parametrization, theimprovementsand the support of MES system (Manufacturing Execution System) within the respect of GMP requirements linked to this system.

Within the frame of activities of Yverdon’ssite, The Engineer M  Design designs the required manufacturing processes in MES (M ) following established rules.

The Engineer M  Design supports the Engineering group with the MES activities (routine’sactivities and qualification’sactivities). ParticipatetoMES activities management linked to manufacturing.

• Realize the MES M  and update the related master data ifrequiredin respect of manufacturing planning.
• Drive and support the M  releaseplanningto deliver on time the required M  for manufacturing activities (routine production, tech transfer).
• Drive the review and technical approval of M  with Manufacturing, Manufacturing Technology and Quality teams.
• Create and manage deviations,investigations and CAPArelated to M .
• Create and manage change controls and change actions related to M .
• Support Manufacturing team and Quality team as MES technical expert for quality events and support proactively the M  continuous improvement.
• Maintain and improve manufacturing operational knowledge with a regular presence on the manufacturing floor and participation in key manufacturing meetings and decisions.
• Participate to MES improvement projects (e.g. interfaces to other systems like SAP, LIMS, PCS) to improve the manufacturing processes and support digitalization.
• Writeand update MES SOP andMES training materials.
• Train MES users.
• ParticipatetoMES On-Call service.
• Participate to audits in case of MES subjects.

• Bachelor’s Degree in relevant field such as pharmacy, biotechnology, chemistry, or equivalent experience in the pharmaceutical industry.
• Thorough knowledge of biotechnological technologies, processes, with a demonstrated experience in computerized and MES systems (PAS-X is a plus).
• Must speak English and French. Excellent written and verbal communication skills.
• Must have minimum of 5 years in an M  creator/MES Admin role in a biopharmaceutical manufacturing environment
• Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to quality, qualification and validation¨
• Be able to work within a highly controlled and demanding environment.
• The ability to make pragmatic and compliant decisions
• Strong result orientation and committed team member

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.