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Lab Validation Analyst
3 months ago
The Lab Validation Analyst is responsible for ensuring that laboratory equipment, systems, and processes are validated according to industry standards and regulatory requirements. This role involves developing, executing, and documenting validation protocols, as well as troubleshooting and resolving validation-related issues. The analyst will collaborate with cross-functional teams to support compliance and continuous improvement efforts within the lab environment.
Essential Duties & Responsibilities:
- Develop and execute validation protocols for laboratory equipment and systems.
- Perform validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Document validation processes and results, ensuring compliance with regulatory requirements.
- Troubleshoot and resolve validation issues, providing technical support to the lab team.
- Collaborate with cross-functional teams to ensure validation activities align with overall project goals.
- Maintain up-to-date knowledge of industry standards and regulatory guidelines.
- Support audits and inspections by providing validation documentation and expertise.
Core Essential Skill Sets:
- Strong understanding of validation principles and practices.
- Experience with IQ/OQ/PQ and other validation protocols.
- Excellent attention to detail and documentation skills.
- Ability to troubleshoot and resolve technical issues.
- Effective communication and teamwork skills.
- Familiarity with regulatory requirements (e.g., FDA, GMP) in a lab environment.
- Proficiency in relevant software tools for validation documentation and reporting.
Position Requirements:
- Education: Bachelor’s degree in Science, Engineering, or a related field.
- Experience: 2+ years of experience in lab validation or a related field, preferably in a regulated industry (e.g., pharmaceuticals, biotechnology).
- Technical Skills: Familiarity with laboratory equipment, validation software, and regulatory guidelines.