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Validation Specialist IV Validation Specialist IV
Ref No.: 18-07657
Location: Westborough, Massachusetts
Expected to be dedicated 100% to the program
Working in collaboration with the ITS Project Leader and / or Validation Lead and other internal and external Business Analysts, load existing User Requirements and create new requirements, risks and other specifications in ALM
Work with Business Analysts and Users as appropriate to gather information necessary to build detailed IQ, OQ / SIT and PQ / UAT Test Scripts, Test Prerequisites and Test Data Sets within ALM and LIMS
Ensure assigned deliverables are submitted to meet required level of quality with minimal defects
Participate and support informal and formal test execution by other ITS and Business team members
Test defect / anomaly tracking and follow-up
Provide to Stream Lead and / or Project Coordinator weekly updates on progress including accurate Estimates to Complete any ongoing tasks
Participate and actively contribute to assigned project meetings
Other tasks and duties as assigned by Sanofi

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Key Attributes Required of Candidates for this Role:
Strong drive to accomplish assigned tasks, a "self starter”
Four or more years prior experience writing technical and / or GXP validation documentation for LIMS implementations in GMP-regulated environment.
Experience in role of a Technical / Validation writer for LIMS project (LabWare LIMS +/- LabWare ELN preferred).
Must have experience developing IQ, OQ / SIT and PQ / UAT scripts and data sets for LIMS.
Must have experience managing script defects / anomalies, supporting / guiding test execution and authoring IQ, OQ / SIT and PQ / UAT summary reports
Deep knowledge and experience applying GXP regulations and Computer Validation principals in support of LIMS validation project
Understanding of Good Document Management principals
Demonstrated technical writing and oral communication skills
Able to work within a team using established methodologies and procedures
Experience managing requirements / specifications, test cases and risks with Client Application Lifecycle Management preferred.
Flexibility to adopt, embrace and work on project under Sanofi PUMA and other related internal processes and procedures, principles and program methodology
Must be a good team player, be motivated to meet commitments, be accountable to achieve goals and targets while maintaining professional relationships
Strong collaborator across all teams and streams in the completion of assigned tasks and those of other team members
Take ownership of assigned tasks and be accountable for their completion as per defined project schedule
Be transparent and thoughtful in communication
Respect needs of various team members and stakeholders
Maintain open and honest relationships with others on ITS and Business teams
Escalate and identify potential issues to IPL and others on the team in a timely and responsible manner
MISSION DELIVRABLES
Requirements and specifications in ALM
Risks in ALM
Test Cases, prerequisites and test data sets in ALM
Pre-executed ("Dry Run”) verified test scripts in ALM
Defect and anomaly records and reports
Validation and other test reports (IQ, OQ / SIT & PQ / UAT Reports)
Other deliverables as assigned by Sanofi