CQV Engineer

Job Title: CQV Engineer Location: Spring House, PA (Onsite) Duration: 12+ Months

Experience: 8+ Years Visa: H1B, US Citizens, Green Card holders only

Summary

We're looking for CQV Engineers to support equipment qualification and thermal mapping for various GMP-regulated systems, especially controlled temperature and lab devices. This role includes protocol development (DQ, IQ, OQ, PQ), authoring validation documents (URS, risk assessments), execution of thermal mapping strategies, support for FAT/SAT, and participation in audits and inspections.

Key Responsibilities

Prepare and execute qualification protocols: DQ, IQ, OQ, PQ

Author and review validation documents: URS, risk assessments, commissioning reports

Define and carry out thermal mapping strategy

Perform FAT/SAT when applicable

Support PCOM/CTP walkdowns

Provide audit and inspection readiness support

What You Need

Hands-on experience qualifying equipment in GMP environments

Strong background in temperature mapping and calibration

Familiarity with GAMP5

Solid understanding of Good Documentation Practices (GDP)

Able to manage multiple systems using a risk-based approach

Skilled in writing and reviewing validation protocols, including handling deviations

Equipment Scope

Controlled Temperature Units & Storage You'll work on qualifying equipment that maintains specific temperature conditions. This includes cryogenic freezers, ultra-low (-80°C) and standard freezers (-20°C), refrigerators, CO2 and general incubators, ovens, and stability chambers.

Laboratory & Safety Equipment Expect to support devices like biosafety cabinets, fume hoods, flammable storage cabinets, lyophilizers, and cryostats.

HVAC & Air Handling Systems This includes AHUs, room HVAC systems (supply/exhaust), control sensors, and equipment connected to the building ventilation system.

Clean Utilities Systems in this category include purified water distribution, clean steam, clean compressed air, nitrogen lines, and possibly WFI depending on the final documentation.

Black Utilities You'll also be working with non-clean systems like electrical panels, emergency power, general lighting, equipment power supply, grounding, technical-use compressed air, and non-GMP heating/cooling loops.

Monitoring & Control Systems This includes environmental monitoring systems (EMS), the client’s building management systems (BMS), temperature and humidity sensors, as well as alarm and notification panels.