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

Department: Field - LL
Location: Trujillo Alto, 139

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.

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