Offre d'emploi : METROLOGY/EMS SPECIALIST

Recruteur
CSM Europe sa
Région
Mont-Saint-Guibert (Commune), Nivelles (BE)
Publication
vendredi 4 septembre 2020
Date limite
mercredi 7 octobre 2020
Type de contrat
CDI
Temps de travail
Temps plein
Langue(s) souhaitée(s)
Anglais, Français

To strengthen our Facilities department, our fast growing company is currently seeking

a highly motivated and enthusiastic

METROLOGY/EMS SPECIALIST

This position is based in Mont-Saint-Guibert (Belgium)

 

Main responsibilities
 

The Metrology-EMS Specialist supports the daily management of the Metrology & EMS division, Validations/Qualification of facilities, equipment and infrastructure:

  • Be responsible for all aspects of Metrology & EMS, CMMS, maintenance of production equipment within the Facilities department;
  • Be responsible for the organization, prioritization and distribution of tasks of the Metrology and EMS division within the Facilities Department;
  • Maintain a close relationship with operational departments to provide support and meet their needs;
  • Collaborate with the Management to address, find and solve any problems occurring on the equipment;
  • Define a planning for maintenance and monitoring of equipment / production facilities;
  • Follow-up and implementation internally, or via subcontractors.
  • Define a planning for maintenance and monitoring of environmental monitoring system;
  • Follow-up and implementation internally, or via subcontractors.
  • Write/Review documents, URS, IQ/OQ/PQ of new installations and ensure the qualifications/validations of those installations;
  • Provide support to operational departments in terms of qualification and validation both annually and for new systems, equipment or infrastructure in line with our quality standards and GxP regulations;
  • Collaborate with the Quality and Operations departments to ensure compliance / write SOPs, WI, and all other documents necessary to perform annual monitoring of equipment/system and installation within his/her areas of responsibility;
  • Support corrective maintenance, CAPA, MOC associated within his/her areas of responsibility in a timely manner;
  • Ensure document monitoring and classification of equipment/systems or infrastructures within his/her areas of responsibility;
  • Manage and update the CMMS / EIC database;
  • Come up with solutions to improve processes and performance of our systems/equipment;
  • Review and approval of calibration certificates and validation documentation

Skills

  • Experience in metrology, validation, qualification
  • Experience of the working environment and experience of standards specific to the Pharmaceutical Industry (GxP)
  • Knowledge of ventilation standards, filtration of clean rooms (asset)
  • Fluent in French and in English
  • MS Office and more specifically Excel (VBA, Script and macro)

Offer

At CSM, we understand our work within the clinical trial process could not happen without our dedicated employees. That’s why we are striving to provide our employees with a challenging working environment which still promotes a work-life balance. We provide competitive compensation and a complete benefits package.

If you have the desire to play your part in making a difference in the lives of patients participating in clinical trials, we want you to apply today by submitting your resume to: HREurope@csmondemand.com

Delivering First Class Clinical Packaging Solutions

CSM is a global company with five sites across the U.S. and Europe dedicated to clinical trial supplies.
Our innovative solutions highlight our flexibility in managing our clients’ clinical trials and allow us to efficiently and quickly deliver medicines to patients in need.

CSM is designed to be agile, which means 100% of our infrastructure is dedicated to making sure our clients’ investigational medical products are packaged, labeled, and shipped on time and with the highest regard for quality.

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