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Validation Specialist III
Ref No.: 17-15100
Location: Westborough, Massachusetts
- Mission: to act in the change control process, supporting the validation as part of the system lifecycle after its goo live. Experience with Vendor audits and ITS internal controls self-assessments is a strong differential .
- Technical skills/ experience: It is very important to have Experience with Commercial operations solutions, such as CRM ( Customer relationship management ) and digital platforms (Mobile apps). Experience with CRM Veeva and Patient support program platforms is a differential.
- Regulations skills: GxP is a must, Knowledge on Data privacy, HIPPA and SOX are a strong differential .
- Year of experience: 5 years with a strong validation experience with Commercial operations Projects and applications ( CRM, for example) would be good enough
Duties
The contractor will act as a team resource on projects or processes defined in the project description, in the following roles:
Provide validation support for multiple IS projects that require computer validation support. This work would be under the supervision of Sanofi personnel. This may include the development and / or review of validation deliverables and activities such as:
Criticality Assessment
Validation Plan
User Requirements
Risk Analysis Report
Specification
Test Plans
Test Script(s)
Anomaly Report(s)
Test Reports
Authorization for Use
Validation Report
Change Management
Support usage of the IS Project Methodology
Will assist with defining validation strategy based on Sanofi procedures
Assist with training on IS compliance topics (e.g. validation)

Skills
Minimum 5 years experience with validation of IS computer systems in an FDA regulated environment.
Understanding of GxP regulations and computer validation principals
Understanding of software development lifecycles
Understanding of document management principals
Demonstrated technical writing and oral communication skills.
Preferred: Scientific education or experience, with test script design, technical document reviews, and strong interpersonal skills.
Experience with the Client Quality Center system is a plus
Preferred: Experience with Commercial Operations
Preferred: Experience with Website/Mobile Application/Digital