Validation Engineer - Computerized Systems
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Validation Engineer - Computerized SystemsApply Now
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
- 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