Validation Engineers
On-siteCaguas, Caguas, Puerto Rico
Job Summary
Author and execute commissioning and qualification protocols, including IQ/OQ/PQ, while supporting field execution and documenting results. Own validation deliverables through discrepancy resolution and closeout for sterile manufacturing, plant operations, facilities, equipment, systems, room requalification, and project-based initiatives. Perform risk-based assessments, support FMEA activities, and coordinate deliverables with QA, Engineering, and Manufacturing across concurrent assignments. Work on-site in El Paso, Texas, with a Bachelor's degree in Engineering and minimum five years of regulated environment validation experience required. Bilingual English/Spanish preferred.
Required 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.
- Strong technical-writing skills.
- Ability to work on-site in El Paso, Texas.
Desired Qualifications
- Bilingual English/Spanish preferred.
- Sterile / combination drug-device manufacturing background.
- Experience with Kneat.
- ISO 14971 / FMEA experience.
- Cleanroom / ISO 14644 experience.
- Validation leadership experience, where applicable.
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