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Validation Engineer (2)Apply Now

Location: Cambridge, Massachusetts 02139
Employment Type: Contract

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Job Description

Contract Length:  6 months; on-site position

Job Summary:  This person will be responsible for executing qualification protocols at the company’s facilities and collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle of the project.

Responsibilities:
 
  • Develops and executes qualification and validation test plans and protocols for systems such as single-use bioreactors, QC instruments, refrigerators, incubators and autoclaves.
  • Develops and executes Environmental Performance Qualifications, analyses results, and generates reports.
  • Develops and executes IQ, OQ and PQ qualification protocols for utility systems.
  • Develops and executes IQ, OQ and PQ qualification protocols for biosafety cabinets.

Requirements:
 
  • Receptive to change – Adapts (quickly) to changing circumstances.
  • Minimum bachelor’s degree in an Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related discipline with 2-4 years (4+ for Sr.) of CQV experience or equivalent professional experience.
  • Self-motivated and must be able to work independently with minimal supervision and direction.
  • Experience in developing and executing protocols in GMP industry.
  • Experience using Kaye Validator and Data loggers.
  • Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

Contact

Eric Carmody
Life Science Recruiting Manager


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