Validation Engineer

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
• Lead 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 MINIMUM QUALIFICATIONS
• 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 EQUIPMENT & WORK ENVIRONMENT
• 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 PREFERRED SKILLS
• ASQ certification (CQE, CRE) preferred
• Familiarity with Six Sigma tools and process capability studies
• Strong project management and cross-departmental collaboration skills LEGAL NOTICE By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from CornerStone and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at : https : / / www.cornerstonestaffing.com / privacy