What are your responsibilities?
As a Validation Engineer you perform qualification / validation activities linked to your part of the business (Computerized Systems).
Your main responsibilities are the following ones :
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 :
Develop the Validation Plans : define validation methodology and approach in line with the Validation Supervisor.
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.
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.
Who are you?
You are graduated as a Master degree in Engineering, Chemistry or Life Science . Your experience in the biotechnology / pharmaceutical industry .
You have 2 years of Experience in CSV and quality systems. You have knowledge of Validation Methodologies, Computerized System Validation, 21 CFR part 11 and data integrity requirements, IT infrastructure qualification, PC S7 and / or EBM.
You have knowledge of Quality Systems, European and FDA regulations, cGMP, GDP and manufacturing processes. You fluently speak English.