CSV Engineer (GSK)
The CSV Engineer is expected to provide an oversight of the project validation activities, lead the development and approval of the validation documentation and risk assessments.
He will work with the project teams to determine which elements should be validated and conduct impact assessments of proposed changes to computerized systems.
TheCSVEngineerwillprovidethenecessaryoversightofsystemrelated issues, employrisk-basedmethodology and ensurethatallGxPcomputerizedsystems are maintained in a validatedstatethroughouttheproject.
Hemayalsoberequiredto train staff on hisown expertise area.
Respect the local EHS procedures related to his work environment
- GMP / CSV:
Serve as the validation expert for the design, implementation, and documentation of the validation activities for manufacturing systems, lab systems and utility / facilities systems.
Perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11, Annex 11 and Data Integrity.
Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices and the company policies and procedures.
Plan and establish technical communications, testing requirements and resources necessary to complete the validation of a system.
Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.
- IT / OT:
Align with Automation & GxP computerized systems Lead and Control System SME regarding technical needs and strategy Administrative:
Ensure that the produced documentation is rigorous, clear, and consistent
- Must have a minimum of 3 years direct CSV validation experience
- Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance,
- including 21 CFR Part 11, Annex 11 and Data Integrity
- Knowledge in computerized system lifecycle activities, CSV and IT controls in a regulated environment
- Solid Knowledge of validation of cGMP automation/computerized systems within regulated environment
- Experience with and knowledge of related quality systems such as Change Control; CAPA and Deviations:
- French full professional proficiency
- English professional working proficiency
Please apply online, Aymeric Shimamungu is your Kelly Contact