Validation Specialist

Job Locations US-MA-North Reading
Posted Date 2 weeks ago(2/8/2018 1:17 PM)
Job ID
Network Success


TraceLink has built the world's largest cloud-based network dedicated to protecting patients, ensuring compliance and growing profits across global life sciences. The TraceLink Life Sciences Cloud is our network, platform and community that links people, processes and information everywhere from ingredient to patient.


Businesses across the globe, including 15 of the top-20 pharmaceutical companies, trust us to help them manufacture and deliver safe, secure medicines to the patients who need them anywhere in the world. We need game changers ready to break down business barriers, master new technologies and become trusted advisors for some of the largest and fasting growing companies on the planet. How will you challenge yourself?


TraceLink is seeking a full-time, experienced “Validation Specialist” to join our team.


The Opportunity:

As part of our Service Products organization, the Validation Specialist works on a product designed to assist customers in validating TraceLink’s cloud-based software through automated test execution. This role requires a combination of analytical, communication (written and verbal) and interpersonal skills to be successful. The Validation Specialist will work closely with a cross-functional team including Product Managers, QA Engineers, Software Developers, Automation Engineers, and customer facing Project Managers. The target candidate will have validation, QA or testing experience with web applications, as well as familiarity with Microsoft office applications. Experience interfacing directly with customers is also strongly encouraged and knowledge of FDA 21 CRF Part 11 and GAMP5 regulations is a plus.


Responsibilities include, but are not limited to:

  • Synthesize information from requirements specification documents, user stories, and acceptance criteria
  • Author, review, and execute test cases based on requirements, stories, and AC
  • Author validation documents, such as Validation Plans, Traceability Matrices, Validation Summary Reports, Functional Risk Assessments
  • Review automated test results and provide guidance for test improvement
  • Participate in customer meetings as an SME for our validation offering
  • Create and setup test scenarios and test data as needed
  • Work with various teams to promote QA processes, practices and standardization



  • Bachelors in Computer Science, Computer Information Systems, Information Technology, Engineering, or related discipline.
  • Experience testing web-based enterprise-class business applications
  • Experience Authoring and reviewing Validation documents, such as Validation Plans, Traceability Matrices, Validation Summary Reports, Functional Risk Assessments
  • Team mindset with demonstrated enthusiasm and ability to work in highly cross-functional, globally diverse organizations
  • Good time management and organization skills, ability to work independently
  • Experience with MS Office suite
  • Effective written and oral communication skills
  • Ability to work in a fast-paced, dynamic environment; enthusiastic team-player
  • Experience in the pharmaceutical industry preferred
  • Knowledge of FDA regulatory requirements, 21 CFR part 11, and GAMP5 a plus


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