A candidate for this position will be responsible to ensure the maintenance of the qualified state for equipment, facilities, critical process utility systems and manufacturing computerized systems which support clinical and commercial manufacturing facilities. Manage and execute the installation qualification, the operational qualification and the performance qualification (IQ/OQ/PQ) of process equipment, the validation of SIP / CIP processes, validation of changes to manufacturing computerized systems and critical process utility systems to assure readiness for intended use to meet policy and compliance requirements
- Executes with guidance from validation leads or management validation efforts associated with the operation of GMP manufacturing systems including installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.
- Execution of testing of required changes to the site Process Automation System (Delta V)
- Execution of testing of process recipes for the Manufacturing Execution System (Syncade)
- Performs assessment of validation work arising from change controls, capital projects, shutdown/changeover activity and ongoing revalidation programs with support from department management
- Technical work assignments and interfaces with project stakeholders. Maintains familiarity with BMS directives and industry guidelines on qualification/validation.
- Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical or mechanical preferred), a related discipline, or its equivalent.
- Co-op or internship experience in biopharmaceutical industry including experience with manufacturing equipment support in the Biotechnology manufacturing industry is desired.
- Familiarity with or interest in process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping concepts is desired.
- Familiarity with or interest in distributed control systems and automation (GAMP) validation concepts may enable this individual to participate in cross-functional validation efforts.
- Excellent project management, communication, and technical writing skills are required.
- Demonstrated effectiveness in both a team environment and an individual contributor role.