Kelly Scientific Recruitment
For one of our clients, we are looking for a validation engineer with a focus on CSV:
The Validation Engineer II performs qualification / validation activities linked to his/her part of the business (Computerized Systems Validation). 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:
1) Prepare and implement the validation documentation required to assure the proper development of a project.
2) 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.
3) 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.
4) Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
5) Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.
6) Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file.
7) Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfillment and EHS.
Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
Minimum 2 years of experience in Validation/Quality systems
Skills: Project management experience
Excellent communication skills, fluent in French and good knowledge of English (written and spoken)
Familiar with Quality Management and GxP Regulations Knowledge of Validation
Methodologies 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.
Sound industry knowledge, project proficiency, and autonomy expected.