MBR Design Engineer

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Incyte Corporation in Yverdon-les-Bains, Switzerland is seeking an Engineer MBR Design to ensure configuration, parametrization and support of MES systems in a GMP environment.

You will design manufacturing processes in MES (MBR), drive release planning, manage deviations and CAPA, and support quality events while collaborating with Manufacturing, Quality and Engineering teams.

Qualifikationen

• Bachelor’s degree in a relevant field such as pharmacy, biotechnology, chemistry, or equivalent pharma industry experience.
• Thorough knowledge of biotechnological technologies and GMP-related regulations; experience with MES systems (PAS-X is a plus).
• Fluent in English and French; excellent written and verbal communication skills.

Aufgaben

• Realize the MES MBR and update related master data in line with manufacturing planning.
• Drive and support MBR release planning to deliver on time for routine production and tech transfer.
• Review and technically approve MBR with Manufacturing, Manufacturing Technology, and Quality teams.

Kenntnisse

English proficiency

French proficiency

Communication skills

Regulatory environment knowledge

Ausbildung

Bachelor’s Degree in pharmacy/biotech/chemistry or equivalent

Tools

PAS-X MES system

Jobbeschreibung

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 ofYverdon’ssite, The Engineer MBR Design designs the required manufacturing processes in MES (MBR) following established rules.

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

DUTIES AND RESPONSIBILITIES

• Realize the MES MBR and update the related master data ifrequiredin respect of manufacturing planning.


• Drive and support the MBR releaseplanningto deliver on time the required MBR for manufacturing activities (routine production, tech transfer).


• Drive the review and technical approval of MBR withManufacturing, Manufacturing Technologyand Quality teams.


• Create and manage deviations,investigationsand CAPArelated to MBR.


• Create and manage change controls and change actions related to MBR.


• Support Manufacturing team and Quality team as MES technical expert for quality events and support proactively the MBR 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.

REQUIREMENTS

• 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 MBR 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.