Lead Validation Engineer – Sterile Manufacturing

QRC Group, LLC; Caguas (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC in Caguas, Puerto Rico seeks a Validation Engineer to support sterile manufacturing validation activities across plant operations, facilities, equipment, and room requalification. The role involves authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.

The position requires a Bachelor’s degree in Engineering, 5+ years of validated experience in a regulated setting, hands-on

Qualifications

• Bachelor's degree in Engineering or related 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, 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.
• Support multiple concurrent projects, depending on assignment.

Skills

IQ/OQ/PQ execution

Validation execution

Regulatory knowledge

Cross-functional coordination

Education

Bachelor’s degree in Engineering

Tools

Kneat

FMEA

Job description

QRC Group, LLC in Caguas, Puerto Rico seeks a Validation Engineer to support sterile manufacturing validation activities across plant operations, facilities, equipment, and room requalification. The role involves authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.

The position requires a Bachelor’s degree in Engineering, 5+ years of validated experience in a regulated setting, hands-on