AT01-011725 Validation Specialist - Laboratory Equipment & Systems (GA)

Validation & Engineering Group-posted 3 months ago
Mid Level
Athens, GA
101-250 employees
Personal and Laundry Services
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We are seeking an experienced Validation & Qualification Specialist to support a laboratory equipment commissioning, qualification, and validation project within a pharmaceutical / FDA-regulated environment. The ideal candidate will have expertise across multiple areas, including validation planning, method transfer, temperature distribution studies, laboratory management system validation, deviation management, and regulatory compliance. Preference will be given to candidates with experience in all these areas.

  • Develop and execute validation plans for laboratory equipment, systems, and processes, ensuring compliance with regulatory standards and SOPs.
  • Perform commissioning, qualification, and validation (IQ, OQ, PQ) activities for laboratory equipment and associated systems.
  • Conduct temperature distribution studies, including temperature mapping for equipment such as freezers, refrigerators, and incubators.
  • Validate laboratory management systems, ensuring proper documentation and compliance with SOPs and FDA guidelines.
  • Support method transfers by providing technical expertise to ensure smooth transitions and compliance with project requirements.
  • Manage deviations by documenting, resolving, and implementing corrective and preventive actions (CAPAs) effectively.
  • Provide regular project updates, track progress, and participate actively in project meetings.
  • Maintain compliance with cGMP, FDA, ICH Q7, Q8, Q9, and other applicable guidelines throughout the project lifecycle.
  • Bachelors degree in engineering, life sciences, or a related field.
  • 3+ years of experience in validation and qualification within pharmaceutical, biotech, or FDA-regulated environments.
  • Proficiency in laboratory equipment validation, including HPLCs, GCs, incubators, and temperature-controlled equipment.
  • Hands-on experience in temperature mapping and distribution studies.
  • Knowledge of laboratory management system validation and associated documentation.
  • Experience with method transfer and managing deviations, including CAPA development.
  • Strong understanding of regulatory requirements, including cGMP, FDA, and ICH guidelines.
  • Technical writing expertise for creating and reviewing validation protocols and reports.
  • Excellent organizational and communication skills to work effectively in a project environment.
  • Experience in laboratory equipment relocation projects.
  • Proficiency in validation software tools and systems.
  • Background in temperature-controlled environments and compliance standards.
  • Opportunity to contribute to a critical project ensuring laboratory equipment and systems meet regulatory standards and operate optimally post-installation.
  • Exposure to diverse technical challenges in a highly regulated environment, fostering professional growth and development.
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