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Lead CSV Engineer for Medical Devices

1 week ago

Dublin, Dublin City, Ireland eir evo talent Full time
Job Overview: We are seeking a seasoned CSV Lead Engineer to join our team. In this role, you will be responsible for leading the development of validation strategies, creating validation output documents, and ensuring compliance with regulatory requirements. This position requires a strong understanding of computer system validation methodologies, GxP guidelines, and ISO standards.

Responsibilities:
- Develop and implement comprehensive validation plans
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
- Create and maintain high-quality documentation, including protocols, reports, and deviations
- Provide technical oversight and lead the overall validation and qualification of equipment and processes

Requirements:
- Must have process/equipment validation experience with CSV knowledge
- Strong understanding of automation process validation and CSV methodologies
- Familiarity with GxP guidelines, FDA 21 CFR Part 11, and ISO standards
- Excellent communication and project management skills

What We Offer:
- Competitive salary and benefits package
- Opportunity to work on exciting projects in the medical device industry
- Collaborative and dynamic work environment
- Professional growth and development opportunities

Why Join Us:
We are a forward-thinking company that values innovation and collaboration. Our team is passionate about delivering high-quality solutions that meet the needs of our clients. If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and cover letter.