consultpharmatek
New Brunswick, United States | Posted on 10/02/2024
Industry: Pharma/Biotech/Clinical Research
Job Type: Contract
Work Experience: 5+ years
State/Province: New Jersey
Country: United States
Job Description
Seeking a CQV Lead specializing in facilities and engineering to oversee the qualification of building utilities, clean utilities, and environmental systems. This individual will be responsible for developing and executing commissioning, qualification, and validation (CQV) protocols to ensure regulatory compliance and traceability to design requirements. Key Responsibilities: Lead CQV efforts for facilities and utilities, including HVAC, water systems, and building automation. Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems. Collaborate with engineering and project teams to align validation activities with construction schedules. Ensure all validation documentation complies with regulatory standards (FDA, cGMP). Conduct risk assessments and develop mitigation strategies for potential compliance issues. Provide cross-functional support and expertise to other CQV activities as needed. Requirements
Qualifications: Bachelor’s degree in Engineering, Life Sciences, or a related field. 10+ years of experience in CQV roles within pharmaceutical or biotech industries. Expertise in facilities, utilities, and building management systems (BMS). Strong understanding of FDA regulations and cGMP requirements.
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Seeking a CQV Lead specializing in facilities and engineering to oversee the qualification of building utilities, clean utilities, and environmental systems. This individual will be responsible for developing and executing commissioning, qualification, and validation (CQV) protocols to ensure regulatory compliance and traceability to design requirements. Key Responsibilities: Lead CQV efforts for facilities and utilities, including HVAC, water systems, and building automation. Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems. Collaborate with engineering and project teams to align validation activities with construction schedules. Ensure all validation documentation complies with regulatory standards (FDA, cGMP). Conduct risk assessments and develop mitigation strategies for potential compliance issues. Provide cross-functional support and expertise to other CQV activities as needed. Requirements
Qualifications: Bachelor’s degree in Engineering, Life Sciences, or a related field. 10+ years of experience in CQV roles within pharmaceutical or biotech industries. Expertise in facilities, utilities, and building management systems (BMS). Strong understanding of FDA regulations and cGMP requirements.
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