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Validation Engineer - Computerized Systems

Lessines, Belgium

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Validation Engineer - Computerized Systems

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Job ID SR0038518 Date posted 09/09/2020 Location Lessines, Belgium

Overview: The Validation Engineer II performs qualification / validation activities linked to his/her part of the business (Computerized Systems). He/She prepares and implements the validation documentation required to assure the proper development of a project. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

Main responsibilities are:

- Prepare and implement the validation documentation required to assure the proper development of a project.

- Act as a validation representative for projects, with support of his/her Validation Supervisor:

  • Define and implement all validation activities related to the project.
  • Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor.
  • Provide validation expertise for the development of the project.
  • Conduct the risk assessment related to the project.
  • Review the URS, FS, DS and DR.
  • Prepare the DQ.
  • Review the commissioning protocols and reports to ensure leveraging into qualification.
  • Prepare the IQ, OQ & PQ protocols.
  • Assure requirements traceability throughout the whole project validation file (from URS to PQ).
  • Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)
  • Analyze, interpret, document and report the testing results.
  • Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
  • Assure feedback of status and issues to the Validation Supervisor.

- Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

- Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

- Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.

- Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file Assuring the ability to meet the Department goals in respect to Quality, Finances, Fullfilment and EHS

- Assuring the ability to meet the Department goals in respect to Quality, Finances, Fullfilment and EHS

Profile requirements:

- BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline

- Minimum 2 years of Experience in CSV and quality systems

- Project management experience

- Excellent communication skills, fluent in english (written and spoken)

- Familiar with Quality Management and GxP Regulations

- Knowledge of Validation Methodologies

- Knowledge of Computerized System Validation

- Knowledge of 21 CFR part 11 and data integrity requirements

- Knowledge of IT infrastructure qualification

- Knowledge od PC S7 and/or EBM is a plus

- Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP

- Knowledge of the manufacturing processes

- Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.Pragmatic.

- Sound industry knowledge, project proficiency, and autonomy expected.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0038518

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