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Job Description
Job Summary: Skilled Computer Systems Validation Engineer sought with experience in software change management and cybersecurity assessments for a global medical device organization.
Responsibilities:
- Validation and operational management of computerized systems
- Creation and review of validation documentation for regulatory compliance
- Software Compliance assessments (e.g. 21 CFR Part 11 and Data Integrity)
- Maintaining quality and compliance status of associated Procedures and work instructions
- Presenting and communicating status, reporting metrics, identifying trends and potential issues
Qualifications:
- Relevant third-level qualification in Engineering/Manufacturing/Science
- 2-3 years of software validation experience in the medical devices industry
- Experience in 21CFR820 and/or ISO13485-regulated industries
Benefits:
- Family health insurance
- Excellent pension scheme
- Life assurance
- Career development opportunities
- Access to a growing business with a new facility
Requirements: A confidential discussion with Kevin Griffin for more information on the role and skills required.