What are the responsibilities and job description for the Equipment Validation Lead position at Intellectt Inc?
Role: Equipment Validation Lead
Location: NC - Onsite
Duration: 12 Months on W2 (No C2C)
Our client is seeking a Lab Equipment Validation Engineer to lead the validation, qualification, and compliance of incubators, refrigerators, freezers, and isolators in a regulated laboratory environment. This role ensures that all equipment meets industry standards, regulatory requirements (FDA, GMP, GLP, and USP), and company policies.
Key Responsibilities:
- Develop, execute, and document validation protocols (IQ/OQ/PQ) for incubators, refrigerators, freezers, and isolators.
- Perform risk assessments and gap analyses to ensure compliance with GMP, GLP, and regulatory guidelines.
- Collaborate with cross-functional teams, including Quality, Engineering, and Manufacturing, to ensure equipment readiness and operational efficiency.
- Investigate and troubleshoot validation deviations and non-conformances, implementing corrective and preventive actions (CAPA).
- Support equipment lifecycle management, including installation, calibration, maintenance, and periodic requalification.
- Generate and maintain validation documentation, reports, and SOPs in alignment with industry best practices.
- Assist in regulatory audits and inspections by providing validation records and ensuring compliance.
Qualifications & Skills:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 3 years of experience in equipment validation within the pharmaceutical, biotech, or medical device industry.
- Strong knowledge of GMP, GLP, FDA, USP, and other regulatory guidelines.
- Hands-on experience with IQ/OQ/PQ validation protocols.
- Familiarity with validation of environmental chambers, temperature-controlled storage, and aseptic isolators.
- Proficiency in risk-based validation approaches, CAPA, and deviation investigations.
- Excellent documentation, analytical, and problem-solving skills.
