Senior Validation Engineer

Role: Senior Validation Engineer

Location: Ireland, Dublin

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

What about the TEAM:

Applied Digital Solutions (ADS) provides full Application Lifecycle Management (ALM) for key products used by ICON in the execution of clinical trials.

This ALM encompasses all phases of the product lifecycle including strategy and business alignment through to product inception, planning, development, marketing and sales support, and product service and support.

We are a very tightly integrated team where collaboration, ownership, and delivery are key foundations of what makes us successful. We are a dynamic team where best in class enterprisedeliveries are a given and quality a must.What about the MISSIONS:

As a Senior Validation Engineer you will be working on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

You will be exercising judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.

• Planning and leading validation and qualification activities for multiple complex projects of any size, which may be regional or global in scope and are 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.

• Coordinating multiple validation and qualification activities with project teams, various departments, and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.

• Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Assessments.

• Creating User Requirements Specifications, and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification.

• Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer III or below.

• Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).

• Create, review, and update SOPs and WPs associate with ICON’s SDLC.

• 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.

• 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.

• Representing Validation Services during sponsor audits and conducting external vendor audits.

• Focus onmeeting  project  schedules;  conducting  System Delivery Lifecyle (and Agile SDLC), Validation,  or  Installation Qualification training; and collects metrics.

What about YOU:

• 5+ Years experience in computer system validation, preferably in clinical systems.

• Experience in process optimization in automated test environment.

• Considerable knowledge of software development life cycle.

• Experienced in serving as technical liaison between end users and testers.

• Proficient with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system validation.

• Excellent interpersonal, written, and verbal communication skills; flexible; works well on a team; strong problem solving ability; good project management skills and excellent collaborative skills.

Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON is an equal opportunity and inclusive employer and 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.

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