Senior CSV Engineer

Role: Senior CSV Engineer

Location: Dublin or Limerick options (Hybrid office/ home working)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

We are seeking a Senior CSV Engineer to join our team. As a Senior CSV 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.

Responsibilities:

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

To succeed you will need:

• Considerable knowledge of software development life cycles.

• 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.

• The ability to work independently on all assignments, meets deadlines, and provides guidance to lower- level validation personnel.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.