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Software Validation Analyst - UK

Software Validation Analyst - UK (2748/1707) Belfast, Northern Ireland

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

We are hiring a Software Validation Analyst to join the team! In this role, you will ensure that all of the computer systems Celerion uses work effectively in a highly regulated environment.

This is a full-time, 100% remote opportunity. You can work from home anywhere in the United Kingdom only.

In this position you will be responsible for direct interaction with internal customers to determine hardware, software and system requirements and to deliver these as GXP systems. They will define and analyze system needs/problems; design and test standards and solutions, create SDLC documentation, and ensure validation documentation meets GxP requirements. They will be expected to organize and conduct project meetings and ensure timelines are established and met as well as liaise with software vendors for support and implementation needs.

Essential Functions*

  • Performs and oversees software project validation in line with departmental SOPs and guidelines.
  • Coordinate cross-functional leads responsible for UAT – providing them with test schedules, test data, direction, and detailed test scripts in accordance with the Release Schedule.
  • Defines application requirements/problem by conferring with clients; evaluating procedures and processes.
  • Develops solutions by preparing and evaluating alternative workflow solutions and analyzing potential software/hardware solutions.
  • Implements solutions by establishing specifications/standards; coordinating production with programmers and/or software vendors.
  • Oversees software installation according to software installation qualification requirements.
  • Validates results by creating testing programs, test cases; performing and coordinating a team of users to execute test cases.
  • Ensures system compatibility with operations by training client personnel; providing ongoing support.
  • Ensures SDLC validation documentation content is complete, maintained and meets GxP requirements.
  • Authoring of all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
  • Accomplishes information systems and organization mission by completing related results as needed.
  • Coordinate IT vendors when working through software issues/defects and resolution paths.
  • Monitor and perform monthly Microsoft patching and testing schedules for regulated applications.
  • Perform system administrator functions for various software applications.
  • Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations
Salary will be based on experience.

Benefits include vacation, pension, life assurance, income protection insurance and private medical insurance.



Education and Skills requirements:

  • Bachelor’s degree in a computer science field OR applicable experience in a medical, clinical, pharmaceutical or analytical setting
  • Experience in a software validation or testing role
  • Experience with MS Office software
  • Awareness of 21 CFR part 11 requirements
  • Awareness of US and European requirements for GMP/GLP/GCP computerized systems
  • Excellent organizational skills
  • Excellent communication skills
  • Excellent problem solving/analytical skills
  • Ability to work remotely from your home
  • Flexibility to accommodate calls outside of normal business hours, when needed

Celerion Values: Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer.