Validation & Engineering Group

LL01-092223 Senior CQV Specialist for Micro / Environmental Lab Equipment


PayCompetitive
LocationTrujillo Alto/Puerto Rico
Employment typeFull-Time

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  • Job Description

      Req#: 2744412

      Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

      We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

      • Senior CQV Specialist with expertise in Microbiology and Environmental Laboratory Equipment

      Qualifications:

      • Bachelor's Degree in Science or Engineering.
      • Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
      • Experience in CQV activities for QA/QC, Microbiology Laboratory Instruments
      • Knowledge of Annex 1 requirements for Gas Sampling.
      • Experience with validation of Climet 97 Instruments is preferred.
      • Experience with generation and execution of Data Integrity testing protocols.
      • Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
      • SDLC, Risk Assessment, Data Integrity.
      • Support to Change Control and Method development activities.
      • Available to work extended hours, possibility of weekends and holidays.
  • About the company

      Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.