Senior Engineer, Manufacturing Systems

SUMMARY

The Senior Engineer – Manufacturing Systems is responsible to maintain, develop, validate and support the activities linked to the Manufacturing and Laboratory computerized systems (MES, LIMS and PIMS) for the Incyte Manufacturing site at Yverdon-les-Bains.

DUTIES AND RESPONSABILITIES

·Ensure that the computerized systems used for manufacturing and QC are configured to cover the data integrity requirement.

·Guarantee that all the validation activities are performed accordingly to the guidance and maintain the validation status of systems among the time.

·Ensure that the systems cover the user requirements.

·Create and manage all the users’ access and provide required users’ trainings.

·Lead or participate to all change requests impacting computerized systems (improvements, master data change, …) and coordinate activities with the rest of E-plant team (MBR designers, interfaces experts, IT, …) or other stakeholders departments.

·Provide expertise and support to the different department whenever needed.

·Ensure that the computerized systems are maintained according to the procedures and that the data audit trail, system audit trail and periodic review are done as defined.

·Ensure that the systems are ready for inspection at any time and provide support during inspections.

·Participate to the MES On-call service.

·Contribute positively to a strong culture of business integrity and ethics.

·Act within compliance and legal requirements as well as within company guidelines.

REQUIREMENTS

·Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Automation or engineering / advanced degree preferred

·Must have at least 5 years’ experience working with automated systems

·Must have at least 3 years of experience in Biotechnology industries and in computerized system’s administration.

·Very good knowledge in Data integrity and Computerized system validation.

·Very good knowledge in GAMP (Good Automated Manufacturing Practices) and Commission & Qualification system.

·Very good knowledge in 2 computerized systems at least (preferably MES and LIMS).

·The ability to make pragmatic and compliant decisions.

·Excellent written and verbal communication skills.

·Must speak English and French

·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.

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