GAMP -GxP Instrument Systems Engineer

VTekis Consulting LLP
Any Location, MA
Category Engineering
Job Description
VTekis Consulting LLC provides complete solutions for Staff Augmentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. We deliver quality professional services to our clients, matching the right professional for their staffing needs.

Requirements

  • Bachelor’s degree or equivalent in science, engineering or computer science discipline
  • 5 to 7+ years’ experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment
  • Direct experience with automation solutions such as Hamilton Venus
  • Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers
  • Experience with GAMP and GxP compliance regulation
  • Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization
  • Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud
  • Strong understanding of core laboratory systems, related processes, and quality management workflows
  • Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally
  • Ability to support multiple concurrent projects in a fast-paced environment
  • Strong interpersonal and relationship-building skills
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