MBR Design Engineer

Incyte; Yverdon-les-Bains; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Incyte is seeking an experienced Engineer MBR Design to ensure configuration and parametrization of the MES system (MBR) in a GMP-compliant biopharmaceutical manufacturing environment. You will design manufacturing processes in MES, support engineering activities, and contribute to MES improvement projects across interfaces such as SAP, LIMS, and PCS.

The role requires a minimum of 5 years as an MBR creator/MES Admin in pharma, with strong GMP knowledge and fluency in English and French.

Qualifikationen

• Bachelor’s degree or equivalent in a relevant field (pharmacy/biotech/chemistry).
• Minimum 5 years as an MBR creator/MES Admin in biopharma manufacturing.
• Proven GMP knowledge and regulatory experience.
• Fluent in English and French; strong written/verbal communication.

Aufgaben

• Realize MES MBR and update master data per manufacturing planning.
• Drive MBR release planning to deliver required MBR on time.
• Review and technically approve MBR with cross-functional teams.
• Create/change controls, deviations, investigations, and CAPAs related to MBR.
• Train MES users and participate in MES on-call and audits.

Kenntnisse

GMP knowledge

Biopharma experience

English proficiency

French proficiency

Problem solving

Quality mindset

Ausbildung

Bachelor’s degree in pharmacy/biotech/chemistry

Equivalent pharmaceutical industry experience

Tools

PAS-X MES

MES admin

Jobbeschreibung

Overview

Summary

As Engineer MBR Design, you will ensure the configuration and parametrization, the improvements and 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’s site, 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’s activities and qualification’s activities). Participate to MES activities management linked to manufacturing.

Duties And Responsabilities

• Realize the MES MBR and update the related master data if required in respect of manufacturing planning.
• Drive and support the MBR release planning to deliver on time the required MBR for manufacturing activities (routine production, tech transfer).
• Drive the review and technical approval of MBR with Manufacturing, Manufacturing Technology and Quality teams.
• Create and manage deviations, investigations and CAPA related 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.
• Write and update MES SOP and MES training materials.
• Train MES users.
• Participate to MES 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