Equipment Validation Engineer, Dallas, TX

Job Title : Equipment Validation Engineer

Location : Dallas, TX

Duration : Long Term

Job Overview :

We are looking for an experienced Equipment Validation Engineer to support qualification and validation activities for our client in Dallas, Texas. The role involves executing validation studies for equipment, utilities, and facilities to ensure compliance with cGMP, FDA, and internal quality standards.

Key Responsibilities :

Prepare, review, and execute IQ / OQ / PQ protocols for equipment and utilities.

Perform temperature mapping and qualification of refrigerators, freezers, stability chambers, and warehouses.

Support facility and utility system validation, including purified water, compressed air, HVAC, and clean steam systems.

Oversee qualification of process and cleaning equipment such as autoclaves, part washers, and sterilizers.

Conduct risk assessments and define validation strategies following GAMP 5 and ASTM E2500 guidelines.

Work closely with QA, Facilities, Manufacturing, and Engineering teams to complete validation deliverables on time.

Maintain validation documentation, traceability matrices, and summary reports.

Participate in equipment change control and requalification activities.

Ensure all documentation meets data integrity and GDP requirements.

Qualifications :

Bachelor's degree in Engineering, Life Sciences, or related field.

2+ years of experience in equipment or facility validation within a GMP-regulated environment.

Hands-on experience with temperature mapping, autoclaves, cleanroom qualification, and controlled temperature storage units.

Good knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and cGMP guidelines.

Strong attention to detail, documentation, and communication skills.