Computer Systems Validation Engineer

at  Abbott Laboratories

HAVE YOU EVER WANTED TO MAKE A DIFFERENCE?

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

QUALIFICATIONS AND EXPERIENCE

• Relevant third level qualification.IT/ Engineering/Manufacturing/Science is preferred.
• 2-3 years working knowledge of software validation in med devices industry.
• Experience carrying out Cyber security assessments.
• Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations

• 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, work instructions.
• Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.