MES Validation Expert - Computer System Validation

Posted 15 Jan 2020

Bari, Puglia - Italy

Req Id 201151

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your Role

 

In the frame of Manufacturing execution system (MES) implementation program ongoing within the Biotech sites, we are looking for a resource accountable for the definition and implementation of an harmonized strategy for the system validation.

You will responsible of supporting, coordinating, harmonizing and executing MES validation activities for a Biotech MES platform for multiple sites located in Switzerland and Italy.  Responsibilities include issue/review for core system for test protocol, test report and other related validation documents (e.g. MVP, SVP, Traceability Matrix, Process Risk Assessment/Analysis, Master Batch record Verification; Configuration Specification, User requirements specification, Functional requirements specification).

You are accountable for the SOP and Computer system validation harmonization through the development of global SOP and Validation standards and content for an MES platform.

 

Who you are

 

•             Degree in Engineering, automation, Informatics, or related area

•             with proven experience in pharmaceutical / biotech environment of at least 3 years; otherwise a proven experience of at least 5 years CSV validation for systems in pharmaceutical / biotech environments

•             MES Validation experience (at least 2 years)

•             Fluent in spoken and written English

•             Profound customer-orientation, with an eye for the company’s own interests.

•             Open for the fresh ideas and new perspectives to be gathered from working with people from diverse backgrounds and cultures.

•             Flexible and keen pursuit of innovation throughout all processes in the continuous search of sustainable new ideas.

•             Willingness to set yourself challenging goals and develop yourself in order to achieve superior performance.

•             Capable to take initiative to constantly improve products, services, processes and working routines.

•             Safety and Quality oriented

•             Keen business acumen

•             Ability to travel 25% to other biotech sites and company offices as required

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement