Senior Validation Engineer - Sterile Manufacturing

QRC Group; El Paso (TX); Hybrid; USD 85,000 - 115,000; Full time

Job summary

QRC Group is seeking a Validation Engineer to support sterile manufacturing validation activities across equipment, systems, facilities, and room requalification projects. The role involves authoring IQ/OQ/PQ protocols, executing field activities, and delivering final validation documents.

The candidate will work on-site in El Paso, Texas, bringing hands-on IQ/OQ/PQ experience, cGMP knowledge, and a strong ability to coordinate with QA, Engineering, and Manufacturing to close out projects.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 5 years of validation experience in a regulated environment.
• Hands-on IQ/OQ/PQ authoring and execution experience.
• Experience supporting equipment, systems, facilities, utilities, cleanroom, and/or regulated manufacturing validation.
• Working knowledge of cGMP and 21 CFR 210/211.
• Ability to work on-site in El Paso, Texas.

Responsibilities

• Author and execute commissioning and qualification protocols and reports, including IQ/OQ/PQ.
• Own validation deliverables through execution, discrepancy resolution, and closeout.
• Execute field activities and document results in accordance with applicable validation requirements.
• Support equipment, systems, facilities, utilities, cleanroom, room requalification, and project validation activities as assigned.
• Perform risk-based assessments and support FMEA activities where applicable.
• Coordinate validation deliverables with QA, Engineering, and Manufacturing.

Skills

IQ/OQ/PQ experience

Discrepancy resolution

Field execution

Risk-based assessment

FMEA support

Education

Bachelor’s degree in Engineering

Tools

Kneat

Job description

QRC Group is seeking a Validation Engineer to support sterile manufacturing validation activities across equipment, systems, facilities, and room requalification projects. The role involves authoring IQ/OQ/PQ protocols, executing field activities, and delivering final validation documents.

The candidate will work on-site in El Paso, Texas, bringing hands-on IQ/OQ/PQ experience, cGMP knowledge, and a strong ability to coordinate with QA, Engineering, and Manufacturing to close out projects.