GxP Validation-Technical Lead Digital Dhara LLC Fort Worth, TX Job Details Contract $60 - $65 an hour 21 hours ago Qualifications Technical engineering GxP GMP Analysis skills Production validation processes Attention to detail Laboratory quality control Biomedical regulatory compliance Quality audits FDA regulations Full Job Description Overview We are seeking a dynamic and detail-oriented GxP Validation-Technical Lead to spearhead validation activities within regulated manufacturing environments. This pivotal role involves leading validation projects to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other regulatory standards such as FDA regulations, ISO 13485, and
ISO 9001.
The ideal candidate will possess strong expertise in quality systems, validation processes, and cross-functional team leadership, driving continuous improvement in quality assurance and regulatory compliance. Join us to lead innovative validation initiatives that uphold the highest standards of quality and safety in manufacturing operations. Duties Lead and coordinate GxP validation activities across multiple projects, ensuring adherence to regulatory requirements and company quality standards. Develop, review, and approve validation protocols, reports, and documentation for equipment, processes, systems, and software in compliance with
GMP, GLP, ISO
standards, and FDA regulations. Oversee risk assessments using methodologies such as Six Sigma and Lean management to identify potential issues and implement effective mitigation strategies. Conduct or supervise qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Perform or oversee quality audits to verify compliance with internal policies, external regulations, and industry best practices. Collaborate with cross-functional teams including manufacturing, engineering, quality assurance, regulatory affairs, and project management to ensure seamless validation execution. Maintain thorough documentation of validation activities, deviations, change controls, and CAPAs (Corrective and Preventive Actions) to support audit readiness. Qualifications Bachelor's degree in Engineering, Life Sciences, or a related field; advanced certifications in GMP or Validation preferred. Proven experience practicing in an industrial or manufacturing engineering role within regulated environments such as pharmaceutical or medical device industries. Extensive knowledge of GxP regulations including FDA guidelines, ISO 13485, ISO 9001 standards, and GMP requirements. Strong understanding of quality audits, quality control processes, and quality management systems. Demonstrated expertise in validation methodologies such as
IQ/OQ/PQ
protocols and risk assessment tools like Six Sigma. Familiarity with GD&T (Geometric Dimensioning & Tolerancing), QA/QC procedures, and regulatory/legal compliance standards in production settings. Excellent leadership skills with the ability to manage cross-functional teams effectively while fostering a culture of continuous improvement. Strong analysis skills for troubleshooting issues during validation activities and implementing corrective actions efficiently. Join our team to lead critical validation initiatives that ensure our manufacturing processes meet the highest standards of safety, quality assurance, and regulatory compliance—making a meaningful impact on product integrity worldwide!
