Sr. Computer Systems Validation Specialist (CSV)
Validation Technologies, Inc - Boston, MA

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Permanent/Full-Time Employee

Outstanding opportunity to make an immediate positive impact on a daily basis while getting to the next level in one's career! Validation Technologies, Inc. is immediately seeking a dynamic and talented Computer Systems Validation Specialist (CSV) to complete our Biotech validation team in the greater Boston, MA area.

VTI offers competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

Validation Technologies, Inc. (VTI) strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Validation and IT Services to the Pharmaceutical, Biotech/Biologics and Medical Devices Industries.


In This Position, You Will:
  • Have a phenomenal opportunity to make an immediate impact within a successful global company!
  • Have a proven track-record of successful computer systems validation (CSV) project execution related to Enterprise Resource Planning systems (ERP systems)
  • Analyze protocol test results, presentation of conclusions and recommendations to clients, ensuring that projects are implemented in accordance with the agreed scope and time lines
  • Organize, schedule and track validation projects in order to meet client requirements and agreed time lines
  • Manage, lead, prepare, review and execute validation protocols and final reports for Ent erpris e Resource Planning ( ERP ) systems

  • Over 2+ years of Computer Validation/ CSV experience within the Biotech/Biologics/Pharmaceuticals/FDA regulated industries
  • Technical degree in related discipline (Computer Engineering, Computer Science, etc.)
  • H ands-on experience and training in Computer System s related to the validation of ERP systems
  • Thorough knowledge of cGMP/FDA regulations & work environment
  • Demonstrated understanding and hands-on experience reviewing technical documents, including, validation documents, IQ/OQ/PQ validation protocols and reports
  • Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
  • Must have strong ability to organize and manage multiple tasks in a fast-paced environment
  • CSV Certification a plus

Validation Technologies Offers:

As one of the leading global Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors.