Career | Validation Engineer | LetsGetChecked

Validation Engineer

LetsGetChecked

Dublin, IE

  • Job Type: Full-Time
  • Function: Engineering QA
  • Industry: Digital Health
  • Post Date: 11/28/2022
  • Website: letsgetchecked.com
  • Company Address: 330 W 38th Street, 405, New York, NY 10018, United States

About LetsGetChecked

LetsGetChecked is a virtual care company that offers at-home testing, telehealth services, and pharmacy capabilities.

Job Description



LetsGetChecked is a leading at-home health testing company, with a platform that allows consumers to discover and access personalized health information conveniently, confidentially and accurately. We empower people to take an active role in their health to live longer, happier lives. LetsGetChecked was founded in 2015 and has corporate offices located in New York City and Dublin.

Validation Engineer

Responsibilities:

    Partner with key business stakeholders to develop policies and procedures necessary to lead the implementation and maintenance of a compliant, efficient and integrated Site Validation program.
    Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.
    Facilitate, prepare and execute Validation documents for Technical Operations, QA and R&D groups, as necessary.
    Develop Test Plan, Test Cases, Test Reports and Traceability Matrix as per business requirements Manage end to end testing / validation lifecycle and provide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc.
    Coordinate with cross function departments to ensure Systems and software are validated for their intended use and solutions are implemented in an efficient and effective manner.
    Evaluate risks, maintain and implement quality systems to ensure compliance with applicable global regulatory requirements.
    Promote adherence to applicable policies and procedures governing computer systems, good documentation practices, and change management.

What we're looking for...

    Bachelor's/Master’s degree in Engineering, Science, Medical or related field.
    A minimum of 2-3 years of experience in systems validation, hands on experience with validation of processes in medical device industry (particularly in Class II/III medical device manufacturing).
    Strong working knowledge and experience of global regulations and guidelines such as GAMP5, 21 CFR Part 11, EU Annex 11 and other FDA regulations i.e. 21 CFR Part 820, ISO 13485, etc. coupled with ability to practically apply such knowledge.
    Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the medical device development life cycle.
    Define risk-based strategies for validation systems and develop end-to-end validation documentation in accordance with various test plans.
    Perform system risk assessments - GxP, Business, and Functional Risk Assessment, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation.
    Provide training related to validation to users and appropriate personnel with in the R&D team.
    Certification / experience in Operational Excellence / Six Sigma highly desired.

 

Why LetsGetChecked?

Together we have a common goal to help people live longer, happier lives.

We want our employees to be healthy, travel often, and have the financial resources and support they need to live a fulfilling life, both inside and outside of work. We encourage our employees to build their careers at LetsGetChecked. We run regular career training clinics, interview assistance, and encourage employees to apply for internal opportunities. We support Learning & Development through our partner Udemy.

Diversity, Equity & Inclusion:

As we continue to grow, LetsGetChecked is fully committed to creating an inclusive environment where diverse backgrounds, perspectives and experiences are valued, where each and every one of our people feels that they belong and are empowered to do the best work of their career.

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