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:
- 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.
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