Senior Computer System Validation Specialist (CSV) - MES

Our client, one of the biggest pharmaceutical companies based in Basel, is looking for a SENIOR COMPUTER SYSTEM VALIDATION SPECIALIST (CSV) with strong experience with PHARMACEUTICAL MANUFACTURING EXECUTION SYSTEM (MES).

This is a CONTRACTING role based in the Basel area and planned to start ASAP until end of the year with extension opportunities.

Are you a COMPUTER SYSTEM VALIDATION (CSV) EXPERTwith PHARMACEUTICAL MES experience environ and currently looking for you next project?

If so, please have a look at the opportunity we can offer you:

PROJECT BACKGROUND:

Our client is looking for a Validation Lead who will be working for the Global Solution Center - Manufacturing IT supporting Pharma Global Technical Operations.

The main focus of this position will be MES (MANUFACTURING EXECUTION SYSTEM). In addition there will be topics around Shop Floor Serialization, Data Analytics and Reporting Solutions.

TASKS:

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Leads a project stream for validation with the objective to set up the CSV of a MES Program (initial Core validation + rollouts)
o Ensures the completion of CSV deliverables in time and in quality
o Ensures the alignment of the different stakeholders
o Collaborates with and gives regular updates to the Project Manager
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Authors, reviews and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, SATs, UATs and Validation Reports
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Escalates non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
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Provides advice, expertise and trains others in the requirements for Quality Assurance and provides input to Informatics process improvement projects and other cross functional program

IDEAL PROFILE:

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Very good understanding of CSV in a pharmaceutical MES (incl. 7+ years of work experience in the relevant area)
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Strong project management skills and delivery focused (incl. 5+ years of PM experience)
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Experience in validation for MES projects (incl. 5+ years of work experience)
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Ability to communicate clear and effectively
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Ability to arbitrate between a wide range of stakeholders to come to a solution (former work experience with stakeholders would be a big plus)
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Strong leadership skills (former work experience as a lead would be a big plus)
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Fluent in English (written and spoken)
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Flexible for business travels (up to 20%)
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Experience in CSV for a global program will be a big asset
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Understanding of the MES process is highly appreciated
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German speaking is a plus

Please note, we can only consider EU/CH candidates or those with a valid work permit for Switzerland.

Are you interested with this opportunity and would like to have more information? Please get in touch with Florence Wespiser ( (see below) )