Validation Engineer

QRC Group, Inc•El Paso, TX

1d•Onsite

About The Position

We are seeking Validation Engineer professionals to support validation activities for sterile manufacturing, plant operations, facilities, equipment, systems, room requalification, and project-based validation initiatives. Assignment may include one or more active site projects, depending on project need. The role includes authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.

Requirements

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.
Strong technical-writing skills.
Ability to work on-site in El Paso, Texas.

Nice To Haves

Sterile / combination drug-device manufacturing background.
Experience with Kneat.
ISO 14971 / FMEA experience.
Cleanroom / ISO 14644 experience.
Validation leadership experience, where applicable.
Bilingual English/Spanish preferred.

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.