Description
Senior Validation Engineer - Limerick, Ireland
Support the activities of Operations/Engineering/Information Management in assuring compliance with the pertinent regulations Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions. Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements. Implement J&J policies and procedures.
Responsibilities:
Responsible for supporting the activities of Operations/Engineering/Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
Runs/Manages complaint investigation and resolution of same
Designs and develops validation documentation to support business continuity, new process introductions
Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Lead by example, inculcating the Credo values in all actions within the workplace
Education and Experience Required
Knowledge of bespoke validation. Process knowledge and documentation.
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
Working experience of validation computer systems for use in a FDA regulated environment.
Have good knowledge of statistical techniques in the use of problem solving/data analysis.
Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.