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Laboratory Validation Specialist

2 months ago

Middleton, United States Infotree Global Solutions Full time

The Laboratory Validation Specialist plays a crucial role in guaranteeing that laboratory instruments, systems, and methodologies are validated in accordance with industry benchmarks and regulatory standards. This position entails the formulation, execution, and documentation of validation protocols, alongside diagnosing and addressing validation-related challenges. The specialist will work in conjunction with diverse teams to bolster compliance and ongoing enhancement initiatives within the laboratory setting.

Key Responsibilities:

  • Formulate and implement validation protocols for laboratory instruments and systems.
  • Conduct validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Document validation procedures and outcomes, ensuring adherence to regulatory standards.
  • Identify and resolve validation challenges, offering technical assistance to the laboratory team.
  • Collaborate with interdisciplinary teams to ensure validation tasks align with overarching project objectives.
  • Stay informed about current industry standards and regulatory guidelines.
  • Assist in audits and inspections by providing validation documentation and expertise.

Core Competencies:

  • In-depth understanding of validation principles and methodologies.
  • Experience with IQ/OQ/PQ and other validation processes.
  • Exceptional attention to detail and documentation proficiency.
  • Adept at troubleshooting and resolving technical challenges.
  • Strong communication and teamwork abilities.
  • Knowledge of regulatory standards (e.g., FDA, GMP) applicable in a laboratory context.
  • Proficient in relevant software tools for validation documentation and reporting.

Position Qualifications:

  • Education: Bachelor's degree in Science, Engineering, or a related discipline.
  • Experience: Minimum of 2 years in laboratory validation or a related domain, ideally within a regulated sector (e.g., pharmaceuticals, biotechnology).
  • Technical Skills: Familiarity with laboratory instruments, validation software, and regulatory standards.