Efrain Suarez Email & Phone Number

Greater Chicago Area

Basel, Baselstadt, CH

Support the development of validation execution strategy and timeline for sustained operation within validated GMP environment.Own validation lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports. Oversee URSs, protocols, reports & support records to ensure compliance; timely resolution of documentation, compliance, and.

Lake Bluff, IL, US

Client 6: Validated environment rooms and freezers for assessing accelerated aging and storage response for sample products, and laboratory sterilizers for the sterilization of laboratory goods in various presentations, in a medium contract manufacturing organization (CMO). Performed or supported equipment setup, testing and validation: This included PQ.

Primarily responsible for providing engineering and regulatory support to product sterilization for US and International manufacturing facilities. Provided technical support to saturated steam sterilization and pasteurization processes (ethylene oxide and ozonation processes on an as required basis). Analyzed, recommended process- and/or product-related.

Primarily responsible of plant instrumentation calibration and IQ/OQ/PQ of all plant critical systems (i.e., saturated steam sterilizers and pasteurizers, compressed air, distilled water, environmental air, pest control systems, etc.), utilities and manufacturing rooms. Prepared and monitored budget according to area activities. Prepared, verified and/or.

Greenville, South Carolina, US

Contract assignment. As part of a multidisciplinary team, responsible of all commissioning activities’ engineering aspects for autoclaves and washers for the Analytical and Microbiology laboratories, and manufacturing equipment within a world-class biotechnology facility. Analyzed, recommended commissioning protocol and plant procedure changes per employer.

Contract assignment. Responsible of providing engineering support to enhance clean in place (CIP) and sterilize in place (SIP) systems for new compounding, holding and filling suites within an updated penicillin manufacturing facility. Analyzed, recommended and helped acquire upgrade parts and components per client regulations and requirements..

Contract assignment. Provided engineering and regulatory support to FDA Consent Decree-related activities for calibration and critical systems. Provided rationale for new site activities and procedures; coordinated these with other sites under the same Consent Decree. Supported Consent Decree-related audit and investigation activities.

Representative of Corporate Sterility Assurance responsible of providing engineering and regulatory support to product sterilization for Caribbean and Latin America manufacturing facilities. Provided technical support to saturated steam, ethylene oxide, electron beam & gamma radiation sterilization, saturated steam pasteurization, and ozonation processes..