Hybrid Senior Validation Engineer

Posted last month

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About the role

  • Conduct validation of custom build and COTS applications
  • Act as guardian of the computer validation process and work across multiple product teams, performing validation activities as per SDLC
  • Oversee official validation execution runs where test automation is not available
  • Conduct validation test activities where required
  • For COTS applications, perform full validation cycles including review of test cases and evidence of execution runs
  • Prepare Validation package, including Validation Plan and Validation Report documents and review other validation documents prepared by development teams
  • Ensure a full audit trail exists for each validated system
  • Look for improvements in the validation process to streamline with rapid delivery cycle
  • Track and manage resolution of bugs or issues generated during validation
  • Serve as the quality gateway for own deliverables; anticipate problems and mitigate impact
  • Represent the company during customer audits relating to computer systems
  • Work independently and collaboratively in a fast-paced, matrixed environment and liaise with Quality Management, Product Management, Engineering, DevOps and IT Operations

Requirements

  • Previous experience within the medical device industry in Quality/Engineering
  • Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and CGMP requirements
  • An ability to effectively communicate ideas to your team-mates and can work as part of a team, regardless of their seniority level
  • Flexible, highly motivated individual and accountable
  • Third level degree but experience and proven track record of 1+ years in testing or validation of computer systems counts
  • A history of having close attention to detail with a high degree of accuracy
  • Experience with or an interest in modern web and mobile technologies
  • Being open to change, new ways for approaching problems and breaking what works before making it
  • Willingness to travel internationally as required
  • Eligible applicants must already hold valid and legal work permit for Ireland (no sponsorship available)

Benefits

  • 25 days holidays
  • Length of Service Awarded Holiday Days
  • Pension
  • Healthcare
  • Life Insurance
  • 50% Maternity leave pay after capped length of service
  • Paid Paternity leave scheme
  • Bike to Work/ Tax Saver Scheme
  • Gym/Wellness Allowance
  • Sports and Social Club
  • Hybrid work option (2-3 days per week onsite)
  • Flexible start/end times

Job title

Senior Validation Engineer

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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