Senior Validation Engineer

Senior Validation Engineer *LI-MB1

Based in Dublin

POSITION SUMMARY

This position works on extremely complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.

JOB FUNCTIONS/RESPONSIBILITIES

• 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.
• Travel (approximately 10%) domestic and/or international.
• Must be able to plan and lead 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.
• 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), 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 III 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 all System Delivery Life Cycle (SDLC) deliverables that are delineated for a Validation Engineer III 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 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.
• 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/designee.

SUPERVISION

• Mentor lower-level validation personnel and assist with their career development and review their work.

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

• Extensive experience in computer system validation, preferably in clinical systems.
• Must have a solid background in hardware and software required to produce a network topology diagram and to ensure that all installation steps are present in an IQ Protocol.
• Considerable knowledge of software development life cycles.
• Must be 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.
• Ability to work independently on all assignments, meets deadlines, and provides guidance to lower level validation personnel.
• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid Driver’s License

EDUCATION REQUIREMENTS

• Bachelor’s degree, or local equivalent, in computer science, mathematics, information systems, information technology or a related field.

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development.  We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.  We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. 

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.  

ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment