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Validation Engineer II (GMF110 et GMF111)-1

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.

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    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.

    Validation Engineer II (GMF110 et GMF111)-1

    Biolife Plasma, Lessines
    Categories: 
    Engineer
    Degree Level: 
    Master
    Apply before: