Cache of job #14008285

Job Title

Validation Engineer

Employer

ICDS Recruitment

Location

Galway

Description

Validation Engineer - Galway. Key Job Responsibilities: • Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems. • Generate collection plans for the qualification and acceptance of incoming components including product sub-assemblies. • Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team. • Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained. • Ensure validation documents are up-to-date (primarily project MVP's and key inputs. • Manage the execution of the product/process validation as per the MVP and project plan. • Work directly with customer validation representatives to define inputs and requirements to the MVP. • Ensure all results and data are correct and follow-up on any gaps or discrepancies. • Liaise with the Engineering function to ensure that equipment validation requirements are maintained from purchase to qualification of new technology equipment. • Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions. • Maintain validation procedures and templates up to date, focussing on continuous improvement. Interested applicants should have: • Level 8 Degree in Science/Engineering with at least 3 years' experience in a similar role within the Medical Devices or related healthcare industry. • Strong knowledge of ISO and FDA quality requirements. • Good understanding of validation concepts and documentation. • Strong communication skills, including ability to advise and influence. • Excellent attention to detail and report writing ability. • Proven ability to work on own initiative. • A general knowledge and experience of statistical analysis methods is an advantage. This job originally appeared on RecruitIreland.com.

Date Added

1835 days ago

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