Offers “Merckgroup”

Expires soon Merckgroup

MES Validation Expert - Computer System Validation

  • Internship
  • Bari (Bari)

Job description



MES Validation Expert - Computer System Validation

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

 

Job Requisition ID: 201151

Location: Bari

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Developer, Biotech, Pharmaceutical, Informatics, Biology, Technology, Science

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