Senior CSV Engineer - Medical Device

Job Description

A great chance for an experienced CSV professional to join a high achieving site team and support on key projects across the site

This CSV Quality Assurance individual will work alongside the Quality Assurance team and will be supporting on validation project and continuous improvement elements for the Cork facility.

This is a hands on role where you will support decision making and project roll-outs for key software projects on site.

A key focus will be ensuring compliance to the site, corporate and regulatory body equipment & automated system and software validation requirements.

This is an individual contributor role with hybrid working on offer.

Key Responsibilities

• Subject Matter Expert on equipment & automated systems validation.
• Strong working knowledge on Software Validation
• Responsible for the review and approval of all documentation through the equipment and automated systems lifecycle.
• Ensure regulatory compliance with internal and external validation regulations, particularly with BSC corporate non-device software requirements.
• Ensure relevant procedures are kept up to date and maintained to the relevant BSC standards and to industry best practice.
• Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all applications supporting the quality system and equipment and automated systems.
• Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
• Provides guidance, training and direction the non device software lifecycles to staff across various functions.
• Provide software validation/compliance/part 11 leadership.
• Take part in vendor audits of critical equipment vendors.
• Present relevant documentation during internal and external audits.

Education & Experience

• Bachelors' degree in relevant STEM discipline with 5+ years experience in ideally a medical device or highly regulated manufacturing environment
• Demonstrated experience planning and executing testing of complex applications
• Demonstrated success working in a highly collaborative, matrix environment, with a track record of accomplishments with measurable business impact
• Strong sense of personal accountability and courage to change how we work
• Proven aptitude to learn quickly and improve processes
• Strong verbal and written communication skills and the ability to collaborate effectively with team members and business partners
• Ability to negotiate, influence, and collaborate to build successful relationships

If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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