Validation EngineerCornerStone Staffing • Irving, TX
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Validation Engineer
CornerStone Staffing • Irving, TX
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionLead execution of validation lifecycle activities : Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Cleaning Validation / Verification Develop and maintain site Validation Master Plans and project schedules per 21 CFR Part 210 / 211 Conduct protocol generation, execution, data analysis, and final reporting for equipment, utilities, and process validations Interface with cross-functional teams (QA, Regulatory Affairs, Engineering, Microbiology, Chemistry) to ensure alignment and documentation integrity Support deviation investigations, risk assessments, and CAPA development tied to validation outcomes 3+ years’ validation or quality engineering experience in regulated drug, food, or cosmetic manufacturing Bachelor’s degree in Engineering, Chemistry, or related scientific discipline Working knowledge of cGMP, FDA validation requirements, and statistical methods (DOE, SPC) Ability to author and review protocols, reports, and technical documentation with minimal oversight Hands-on involvement with pharmaceutical equipment and manufacturing systems Exposure to hazardous waste (e.g., solvents, inks, mercury); EPA-compliant handling training required Work includes interaction with cleanrooms, controlled environments, and lab-scale / production-scale machinery ASQ certification (CQE, CRE) preferred Familiarity with Six Sigma tools and process capability studies Strong project management and cross-departmental collaboration skills
Position : Validation Engineer
Location Carrollton, TX | Onsite
Compensation & Schedule
- Pay up to $42 / hr
- Full-time hours - Mon - Fri
- W2
ROLE IMPACT
This role leads validation engineering efforts to ensure cGMP compliance in OTC drug manufacturing. The engineer executes qualification and validation of systems, processes, equipment, and cleaning procedures aligned with FDA regulations. Success is measured by robust, audit-ready documentation and continuous improvements in process reliability, product quality, and compliance.
KEY DUTIES
MINIMUM QUALIFICATIONS
EQUIPMENT & WORK ENVIRONMENT
PREFERRED SKILLS
LEGAL NOTICE
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Validation Engineer • Irving, TX
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