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Reference # : 17-91435 Title : Validation Specialist III
Location : Westborough, MA
Experience Level : Start Date / End Date : 01/03/2018 / 04/06/2018  
Job Title: Validation Specialist III (7632689)
Duration: 3 Months
Location: Bridgewater, NJ
Client: A Big Pharmaceutical Company

  • 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.
  • 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 Client 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 Client procedures
  • Assist with training on IS compliance topics (e.g. validation)
  • 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 HP Quality Center system is a plus
  • Preferred: Experience with Commercial Operations
  • Preferred: Experience with Website/Mobile Application/Digital
Bachelor degree: Computer Science (preferred) or Business/Sciences with computer science concentration. 

Required Skills:
  • Computer Validation
  • FDA
  • GXP
  • Risk Analysis
  • Software Development
Additional Skills:
  • Change Management
  • Document Management
  • Operations
  • Structured Software
  • Test Plans
  • Test Reports
  • Training
Ridhi Thapa
Pharma Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.295.4583 | Fax: 973.998.2599
Email: | Website:
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check:

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