Senior Engineer Lab Systems - Yverdon-les-Bains, Schweiz - Incyte

Beschreibung

Summary

As part of the Engineering department, The Senior Engineer Lab Systems & Equipment is responsible to develop, validate and ensure that Lab system (LIMS/ELN) and complex Laboratory Equipment systems used in the Bioplant follow the cGMP policies, cGMP, Swiss, EU / US FDA Regulations. This role is administrator of LIMS QC system and complex laboratory equipment used in BPS, QC and Production. He will ensure that the documentation such as periodical qualification, change control are created and followed as required.

DUTIES AND RESPONSABILITIES

Global LIMS administration – Lab System:

·Provide the training material for the LIMS/ELN Local users

·Create and manage all the access and all the change request on LIMS/ELN, and check the impact for the other sites using LIMS

·Participate or lead to improvement project linked to LIMS/ELN

·Ensure that LIMS/ELN is maintained according to the procedure and that the periodic review is done as defined

·Ensure that LIMS/ELN is ready for inspection at any time and follow the data integrity procedure

·Ensure that LIMS/ELN is programmed according to business/compliance needs

·Ensure data integrity compliance of LIMS/ELN systems

·Ensure regular & appropriate reporting of the LIMS/ELN status has to be provided to the Manager

Administrator and Maintenance Lab Equipment:

·Administrate Complex lab equipment, access rights, software updates management, for following complex laboratory equipment: HPLC, UPLC, Solo VPE, Osmometer...

·Participate or lead to improvement project linked to any laboratory systems

·Participate or lead new lab equipment implementation

·Ensure that the systems and equipment are maintained/qualified and correctly documented according to the procedures in place (GMAO included)

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

·Ensure data integrity compliance of Lab equipment

·Ensure regular & appropriate reporting of the Lab Equipment status has to be provided to the Manager

Main responsibilities

·Act as the main point of contact for LIMS/ELN and complex lab equipment for the Bioplant

·Manage and follow up: change controls, documentation, trainings, periodic reviews, unexpected events and CAPAs

·Contribute and support the elaboration of periodic reviews and periodic system and data audit trails review of equipment/systems within the scope of responsibility

·Support the Health Authorities inspections through your personal expertise field

·Present specific topics to health authorities

·Back-up of Quality Champion for E&M department

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

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

·Delegate to: head of E&M

·Coach and support other team members for lab systems and equipment compliance matters (such as deviation and changes management)

REQUIREMENTS

·Engineering educational background preferably in Chemistry, Bioprocessing, technical engineering or laboratory

·10 Years experience in the biotech, pharmaceutical or chemical industry environment.

·Hand on experience of equipment and software qualification

·Very good knowledge in LIMS system (Labware is a plus)

·Demonstrated solid hands on experience in GMPs – 8-10 years

·Ability to work in a fast paced – high regulated environment

·French and English (fluent)

·Capacity to perform task in a highly qualified environment

·Team work oriented mindset

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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