Senior Validation Engineer

Overview Human Resources Officer | Bachelor of Business Studies | HR
About Teckro
Teckro aims to simplify and modernize clinical trials. Thousands of clinical trial investigators and research site staff rely on Teckro to help make informed decisions for their patients. We’re offering you a role with purpose where your contribution will support faster, safer and more efficient clinical trials. Quality of life will be improved and lives will be saved.
Could you be our newest Teckronaut?
What you’ll Do You will be conducting validation of custom build and COTS systems.
You will be the guardian of our computer validation process and work across multiple product teams, performing validation activities as per our SDLC.
For custom build applications, you are responsible for overseeing official validation execution runs where test automation is not available, and you will conduct validation test activities where required.
For COTS applications, you will be responsible for full validation cycles including review of test cases for continued suitability and effectiveness and reviewing evidence of execution runs as per our processes.
You will prepare a Validation package, including a Validation Plan and Validation Report documents and review any other validation documents prepared by development teams, ensuring a full audit trail exists for each validated item.
You will look for improvements in our validation process to make it as streamlined as possible so it works in tandem with our rapid delivery cycle.
You will be responsible for tracking and managing the resolution of bugs found or issues generated during validation.
You will take responsibility for being the quality gateway for your own deliverables.
You will anticipate problems proactively and take appropriate actions to mitigate impact.
You will represent the company during customer audits relating to computer systems that you validate.
You will work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external teams.
You will liaise with Quality Management, Product Management, Engineering, DevOps and IT Operations to contribute to Teckro products.
The Ideal candidate will have Experience within the medical device industry in Quality/Engineering is preferred.
Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and CGMP requirements.
Ability to effectively communicate ideas to teammates and work as part of a team, regardless of seniority.
Flexible, highly motivated, and accountable.
Qualifications Required Third-level degree, with 1+ years in testing or validation of computer systems (experience counts).
Close attention to detail with a high degree of accuracy.
Experience with or interest in modern web and mobile technologies.
Open to change and new approaches, and the ability to break what works before making it better.
Location and Travel (Dublin/Limerick)
Hybrid work option with 2-3 days per week onsite in Dublin or Limerick City.
Flexible start/end times to suit your lifestyle.
Willingness to travel internationally as required.
Please note: Regrettably we cannot offer work permit/sponsorship or self-sponsorship for this role. Eligible applicants must already hold valid and legal work permit for Ireland.
25 days holidays
Length of Service Awarded Holiday Days
Pension
Life Insurance
50% Maternity leave pay after capped length of service
Paid Paternity leave scheme
Bike to Work/ Tax Saver Scheme
Sports and Social Club
Additional We are always looking for amazing people to join our growing team. If you are curious, passionate and motivated, then we want to talk to you
By submitting your application, you agree that Teckro may collect your personal data for recruiting and related purposes. Teckro’s Recruitment Privacy Statement explains what personal information Teckro may process, where Teckro may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Teckro’s use of your personal information.
Seniority level Mid-Senior level
Employment type Full-time
Job function Industries: Software Development
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