VALIDATION MANAGER

Duties : This position has multiple responsibilities within the cGMP Cell Manufacturing Facilities group that supports the CVPP.

Manage the Preventative Maintenance and Calibration programs to ensure all equipment (centrifuges, freezers, incubators, cell counters, etc.

remain in good working order and complaint with cGMP and FACT standards. Coordinate activities with internal scheduling and external vendors.

Manage equipment repairs and risk assessments to ensure equipment remains in a qualified state.

Manage the qualification of facilities and equipment in CACT and Ravdin such that they remain in a state of compliance with internal Validation Master Plans and cGMP / FACT regulatory standards.

Oversee the Cleaning Validation program and support EM and personnel monitoring programs Create, execute and review IOPQ protocols for new and existing equipment.

Provide oversight for compliance of the clean room facilities to ISO 14440 standards including ISO Class 5, 7 and 8 environments.

Manage the BioSafety Cabinet certification program to ensure the integrity of the aseptic processing environments. Coordinate with vendors for room balancing and HEP / certifications.

Manage the building monitoring system and annual qualification.

Author, review and revise Standard Operating Procedures (SOPs) for equipment operation and maintenance. Train Manufacturing and Facilities staff on procedures.

Manage Deviations from Procedure (OFPs) and Corrective Action / Preventative Actions (CAPAs) as part of the CVPF overall continuous improvement program.

Ensure forms are complete and accurate.

Collaborate with the Manufacturing teams to identify new equipment technologies, assess equipment capabilities and potential standards for qualification.

Act as primary expert for equipment trouble-shooting.

Qualifications : Minimum BS in Engineering or related Science and minimum 5 - 7+ years work experience in FDA, FACT accredited or related regulatory field or an equivalent combination of education and experience required.

Excellent understanding of MS Office suite, project management software and building management programs. 5+ years experience managing clean room environments such as ISO Class 5, 7 and 8 required.

5+ years experience with equipment qualifications. Cleaning validation experience is a plus.

5+ experience with general laboratory equipment such as centrifuges, BSCs, incubators, freezers required. Experience with high-tech equipment such as cell counters, cell washers, elutriation and micro-fluid dispensers preferred.

Excellent organizational skills and ability to problem solve complex problems required. Excellent communication skills with a customer service mind set required .

Ability to identify tasks, prioritize and resolve in a systematic manner required.

Reference Number : 40-29769

Salary Grade : 028

Employment Type : Exempt

Org : CI-TCSL / CVPF

Special Requirements :

Job Family : B-Executive / Managerial Administration