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AT01-062425 CQV Engineer – Controlled Storage and Cryogenic Systems (PA)

Department: Field - USA
Location: Spring House, PA

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

We are currently seeking a CQV Engineer with expertise in cold chain equipment and cryogenic storage systems to support commissioning and qualification of GMP-controlled environments. The selected candidate must be available to work in laboratory and production support areas, complying with all safety and gowning requirements.

Location: Spring House, PA

Responsibilities:

  • Author, review, and execute IQ and OQ protocols for cold storage and cryogenic systems, including:
    • Freezers, refrigerators, and cryogenic storage units
    • Controlled rate freezers and automated cryopod systems
    • Cryopod filling and transfer stations
    • Temperature monitoring and alarm systems
  • Develop and execute thermal mapping protocols and support calibration activities.
  • Perform equipment walkdowns and ensure commissioning readiness of temperature-controlled equipment.
  • Document commissioning and qualification activities using Good Documentation Practices (GDP).
  • Support deviation management and ensure traceability to design and risk documentation.

Qualifications:

  • Bachelor’s degree in engineering, life sciences, or a related technical field.
  • 5+ years of CQV experience with cold chain and cryogenic systems in GMP environments.
  • Strong experience with thermal mapping, monitoring/alarm testing, and calibration procedures.
  • Familiarity with risk-based qualification, URS/FRS traceability, and validation lifecycle documentation.
  • Strong communication and problem-solving skills, with the ability to work independently and in teams.

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