Lead Validation Engineer

2 weeks ago


Irving, Texas, United States BEPC Inc. - Business Excellence Professional Consulting Full time

Key Responsibilities:

  • This role is responsible for overseeing the validation processes of systems to ensure they meet business requirements, user expectations, and regulatory standards. The engineer will develop, document, and execute engineering studies, design experiments, and create Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols and reports.
  • Additionally, the engineer will create, review, and approve validation documentation and Standard Operating Procedures (SOPs) for the department. Acting as the team lead on validation project teams, this position will guide team activities to ensure compliant solutions are achieved.
  • Identify opportunities for process enhancements and develop proposals aimed at optimizing processes. Establish machine and process standards to improve overall equipment efficiency.

Position Duties:

  • Conduct equipment validation, including Installation, Operational, and Performance Qualifications (IQ, OQ, PQ), ensuring compliance with equipment, process, and systems validation regulations.
  • Must possess knowledge of J&J Validation Methodology.
  • Plan, schedule, and manage validation projects while providing leadership, mentoring, and supervision to team members involved in validation activities.

Core Competencies:

  • Strong communication skills are essential, with the ability to provide regular updates to both internal and external stakeholders.
  • Demonstrated project management skills with a proactive work approach.
  • In-depth validation knowledge adhering to J&J guidelines and a comprehensive understanding of Good Documentation Practices (GDPs).
  • High proficiency in computer applications.
  • Commitment to high work standards and meticulous attention to detail.
  • Exceptional planning and organizational skills.

Education & Experience Requirements:

  • Bachelor's Degree in Science or Engineering.
  • A minimum of 5 years of experience as a Validation Engineer in the medical device, pharmaceutical, or similarly regulated sectors.
  • Experience across all aspects of IQ, OQ, PQ, and Process Development Validations, along with familiarity with ISO 13485 and a solid understanding of FDA and MDD GMP requirements concerning medical devices and/or pharmaceuticals.
  • Proven expertise in product verification and process validations, including software.
  • Desirable knowledge and experience with Geometric Dimensioning and Tolerancing (GD&T), Six Sigma methodologies, and Statistical Engineering.
  • Desirable familiarity with laboratory equipment.

This position will report to the LIMS Administrator, who oversees and supports the laboratory information management system, a software application designed to assist laboratories in managing their workflows and data efficiently.



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