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Computer Systems Validation Engineer

  • Sector: Engineering
  • Contact Email: kevin.griffin@collinsmcnicholas.ie
  • Job Ref: 22820

Our client is seeking a skilled Computer Systems Validation Engineer with experience in software change management and cybersecurity assessments. This role offers the opportunity to join a global medical device organization.

Responsibilities

  • The validation and operational management of computerized systems.

  • The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.

  • Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.

  • Maintaining the quality and compliance status of associated Procedures, and work instructions.

  • Presenting and communicating status, reporting metrics, identifying trends potential issues, and improvement initiatives, as applicable.

Qualifications and Experience

  • Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.

  • 2-3 years of working knowledge of software validation in the medical devices industry.

  • Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider the experience in pharmaceutical validations

Benefits

  • Family health insurance,

  • Excellent pension scheme

  • Life assurance

  • Career Development

  • Fantastic new facility

  • Growing business plus access to many more benefits.


For a confidential discussion and more information on the role, please contact Kevin Griffin

kevin.griffin@collinsmcnicholas.ie

(021) 2427108