Software Validation Specialist
New York, NY

Job Description

Validation Analyst II

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This person will be providing testing/validation support specializing in test script writing, execution, and documentation.

Overview of the Role

* 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 2%) domestic and/or international
* *Conduct testing activities according to relevant ICON Standard operating procedures (SOP's) and appropriate regulations.
* *Write and execute formal test scripts and complete associated documentation and ensure test results are reported accurately.
* Complete test script writing and execution for moderate to complex systems.
* Authors and reviews key validation deliverables such as Validation Plan, Validation Summary Report, Traceability Matrices.
* Function as testing lead for assigned projects including, but not limited to, planning the test effort and write test scripts ensuring system performs as intended.
* Assess system for 21 CFR Part 11 Compliance and associated documentation.
* Assist lead/manager and/or project team in client audits and/or regulatory inspections for queries related to Laboratory IT Systems.
* *Communicate with lead/manager and/or project team regarding system testing progress and issues.
* Complete assigned tasks within timeline constraints and report any quality issues to lead or manager in a timely manner.
* *Liaise with technical project manager in the testing and implementation of systems.
* Other responsibilities may be assigned as required.

Role Requirements

* To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* US/LATAM/CAN: minimum 4 years of experience in software testing/validation in a regulated environment.
* EU/APAC: Prior proven experience in software testing/validation in a regulated environment.
* Successfully manage multiple tasks and timelines.
* Liaise professionally with team members and system users.
* Basic understanding of SQL and database concepts.
* Knowledge and hands-on experience in Test Automation Tools or Application Lifecycle Management (ALM).
* Prior proven experience in testing application in Water Fall or Agile /Scrum development process.
* Prior proven experience in all aspects of Software Validation Life Cycle (SVLC) such as Validation Plan preparation, Test Script preparation, Test execution, Defect reporting and tracking, Traceability Matrix preparation, Validation Summary Report preparation.
* Prior proven experience in Black Box Testing, Graphical User Interface (GUI) Testing, User Acceptance Testing, Database Testing, System, Functional, Smoke, Sanity, and Regression Testing.
* Prior proven experience in testing various applications developed in Java, .Net, Oracle, MySQL and C .
* Experience in performing 21 CFR Part 11 Assessment for applications to ensure compliance to the regulation.
* Experience and participation in audits from clients and/or inspections from regulatory bodies.
* Knowledge of regulatory guidelines and regulations such as GCP, GLP, 21 CFR Part 11, Annex 11 etc.
* Knowledge and hands-on experience with validation of mobile applications in a regulated environment.
* Perform assigned tasks with little or no supervision.
* Strong verbal and written communication skills
* Bachelor's degree, or local equivalent, in information systems, science, or related discipline or relevant experience.
* An alternative combination of experience, education and training determined by management to be equivalent to the foregoing.

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.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.