This position works on extremely complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
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
Overview of the Role
· 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 all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer III or below.
· 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.
- You will have a Bachelor’s degree, in computer science, mathematics, information systems, information technology or a related field.
- Prior relevant experience in computer system validation, preferably in clinical systems.
- Familiar with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system validation.
- Test, troubleshoot, and qualify equipment and PC based laboratory automation and analytical systems used in a FDA / EMA regulated environment
- Experience in the IQ/OQ/PQ for laboratory equipment used in a FDA / EMA regulated environment.
Benefits of Working in ICON
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.
What’s Next? –
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment