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Sr Validation Engineer - Biotech GMP (JP8135)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Sr Validation Engineer - Biotech GMP (JP8135)
Location: West Greenwich, Rhode Island 02817
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 19 November 2020
Note: Remote until COVID-19 restrictions are lifted.
 
3 Key Consulting is hiring a Sr Validation Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • Candidate will be remote during COVID yet required to be on site when needed!
  • 6+ years of experience within GMP regulated environment (pharma or biotech preferred)
  • Bachelor’s Degree minimum - Life Sciences or Engineering
  • Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems.
  • Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries.
  • Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

Top Must have Skill Sets:
  • Project Management - large skill projects
  • GMP/GAMP Subject Matter Expert
  • Data Integrity Knowledge
 
Day-To-Day Responsibilities:
  • Capital project validation strategy and execution
  • Change control assessment and management
  • Data integrity assessments
 
Employee Value Proposition:
Great team dynamic, exposure to cross functional teams & exposure to different departments
 
Red Flags:
  • No GMP or operations experience
  • Less than 6 years of experience
 
Interview Process: Phone & Video WebEx 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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