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Tek Support
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Senior Validation Engineer

Senior Validation Engineer

Tek Support

10 years

0 Lacs

Hyderabad Telangana India

Posted:1 day ago| Platform:

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Skills Required

mapping documentation support data integrity risk planning compliance strategies commissioning test audits stability sensors electrical power lighting monitoring

Work Mode

On-site

Job Type

Contractual

Job Description

Job Title:

Location:

Position Summary:

senior CQV Engineer Trainer

(DQ/IQ/OQ/PQ),

Key Responsibilities:

Prepare and execute qualification protocols: DQ, IQ, OQ, PQ
Develop and implement thermal mapping strategies for controlled environment equipment
Author and review validation documents, including URS, risk assessments (e.g., SIA), and commissioning test reports
Conduct FAT/SAT, PCOM readiness walkdowns, and deviation resolution
Support internal audits and regulatory inspections
Coordinate qualification efforts across multiple systems using a risk-based approach
Ensure compliance with GDP, GAMP5, and applicable regulatory standards

Systems in Scope:

Controlled Temperature Units

Cryogenic and ULT freezers, -20°C freezers, refrigerators, CO₂ incubators, ovens, and stability chambers

Laboratory and Safety Equipment

Biosafety cabinets, fume hoods, lyophilizers, cryostats, flammable storage

HVAC & Environmental Systems

AHUs, room HVAC, local exhaust systems, HVAC sensors and controls

Clean Utilities

Purified Water (PW), Clean Steam, WFI (if applicable), Clean Compressed Air, Nitrogen lines

Black Utilities

Electrical panels, power supply, lighting, grounding systems, cooling/heating loops

Monitoring & Control Systems

EMS, BMS, temperature and humidity sensors

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