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Senior Validation Engineer

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About the role

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Senior Validation Engineer
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. To validate and document in-house developed systems as well as provide mentorship and training to the IT Validation team members.
 
Overview of the Role
  • Recognize, exemplify  and adhere to ICON's values which centers on 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 5%) domestic and/or international.
  • *Oversees the development and implementation of IT Validation plans.
  • *Develops, approves, executes, and reviews test scripts for completeness, accuracy and adherence to policies and procedures.
  • *Detects and reports testing errors.
  • *Evaluates Defects/Change Requests and perform testing that is required.
  • *Develops or oversees development of traceability matrices and validation summary reports.
  • *Acts as main contact person for IT groups during the implementation of a new system.
  • Training of users on new systems.
  • Author SOP's - how to use systems.
  • Overall document management for all validation deliverables including, but not limited to: managing all aspects of validation package contents; assisting in the routing/approval process of documents; archiving documents.
  • Participates In external client audits for IT Validation functions.
  • Formulates responses to external client observations and inquires.
  • Conducts/participates In external vendor audits and assessments.
  • Can act as the IT Validation representative at meetings with other departments.
  • Recommends new processes to increase the performance of the department and increase quality of its functions.
  • Mentors and trains new members of the department on the validation process and error reporting.
  • *Manage validation schedule and testing.
  • *Coordinate team of testers.
  • Performs additional responsibilities as requested by Management.
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.
  • Four or more years of relevant experience
  • Knowledge of Regulatory guidelines, 21 CFR Part 11, PACS, FlexSite, ICOLabs, SOP's, all ICOLIMS related systems, and Software Development Life Cycle processes.
  • Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
  • Excellent communication including written, verbal, and listening skills.
  • Self-motivated, detail oriented, takes Initiative and ability to work independently without close supervision.
  • Minimum BA I BS In information systems, engineering, or science or local equivalent.
  • Active membership In industry organizations (i.e. American Society for Quality, Regulatory Affairs Professional Society, AAMI, ISO).
  • Desired-
  • Certification in a regulatory field or certification and/or external trainings historically.
  • Experience/Training in IT project Management.
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.
 
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