Principal Validation Engineer

The Principal Validation Engineer works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments and may supervise the activities of other lower-level personnel.

• What you will be doing:
  
  

  Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Must be able to plan and lead validation and qualification activities for an extremely complex large global project and other validation and/or qualification projects occurring at the same time, ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICON and the FDA.
  • Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), and Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.
  • Must be able to conduct meetings for a Risk Impact Assessment (RIA), Validation Risk Assessment and 21 CFR Part 11 Assessment.
  • Must be able to create a User Requirements Specification, and assist in the creation of a Functional Requirements Specification and the Technical Design Specification.
  • Must be able to create all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer IV or below.
  • Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).
  • Must be completely proficient in all ICON Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving the System Delivery Life Cycle (SDLC) deliverables that are delineated for a Validation Engineer IV or below
  • Must be able to create, review, and update SOPs and WPs associate with ICON’s SDLC.
  • Must be able to conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time.
  • Must be able to work with other business units in the Information Technology department and other organizational departments to improve processes and streamline validation and/or qualification efforts.
  • Must be able to create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to ICON personnel and to external audiences.
  • Must be capable of representing Validation Services during sponsor audits and conducting external vendor audits.
  • Focus on meeting project schedules; conducting SDLC, Validation, or Installation Qualification training; and collects metrics.
  • Keep supervisor and project managers informed of any validation or qualification issues.
  • Additional duties as deemed appropriate by the department head/designed.

You are:

• Bachelor’s degree or equivalent in a IT, scientific or health-related field
• Minimum of 3 years experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice.

  • Read, write and speak fluent English; fluent in host country language required

         

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.