Cache of job #13535319

Job Title

Senior Validation Engineer

Employer

Pe Global

Location

Limerick

Description

POSITION SUMMARY: A minimum of 5 years industry experience in a Medical Device/Pharmaceutical industry or a similar operating environment. GENERAL SCOPE OF RESPONSIBILITIES: 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 Johnson & Johnson Validation Policies and Procedures are addressed. Serves as technical expert for the Validation process and responsibilities to ensure compliance. 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. 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. Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Johnson & Johnson Policies and Procedures. QUALIFICATIONS AND EXPERIENCE: A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience. Minimum of 5 years working in a regulated environment and a minimum 3 of which has been spent carrying out validation and/or testing activities. 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. ESSENTIAL: • A minimum of 5 years experience in Validation in a regulated environment. Please call Lisa O'Sullivan on 021 4297 900 for more info or email your up to date CV to lisa.osullivan@peglobal.net. Validation Engineer, Job, Limerick, This job originally appeared on RecruitIreland.com.

Date Added

2774 days ago

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