Posted on Feb 1, 2019 by Bristol-Myers Squibb Company
- 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.
Ipsen Biopharmaceuticals, Inc.