Senior Validation Engineer / Validation Lead
To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Validation Policies and Procedures are addressed.
Responsibilities
- Serves as technical expert for the Validation process and responsibilities to ensure compliance
- Continuous Learning/Managing Risk Resolves & manages technical operational problems in area of expertise
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas
- Manages relationships externally and internally.
- Builds cross functional and cross-departmental support, fostering overall effectiveness
- Fosters harmony within Quality Systems.
- Influences and persuades so as to bring about technical and process improvements.
- Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
- Ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
Requirements:
- Minimum education of degree in a technical field is preferred.
- Minimum 4 years’ experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.
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