This position provides technical expertise and operational support for the design, installation, start up, and routine operation of new aseptic filling equipment within the B41 Injectables operation. Partners with shop floor colleagues and supervision to ensure completion of appropriate start up and qualification activities, including assistance with equipment troubleshooting as needed. Key accountabilities include ensuring all equipment functions as intended to successfully manufacture drug products on schedule, and all product is produced in a manner meeting safety and quality requirements.
- Develops and validates manufacturing equipment and processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.
- Leads Operational team in the review and approval of associated qualification documentation
- Conducts tests and measurements throughout stages of start-up and production to determine control over applicable variables.
- Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
- Identifies and implements cost savings ideas, specifically line efficiency improvements and other projects that increase equipment capacity.
- Serves as subject matter expert on future equipment purchases or improvements; interface closely with engineering to specify user requirements, review and approve drawings, define project scopes, develop and execute equipment acceptance testing and validation criteria, develop and execute equipment acceptance testing and validation criteria.
- Investigates deviations that occur on the manufacturing floor. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
- Successful candidate must be familiar with tools and techniques required to manage large scale complex projects through multi-disciplinary teams.
- An aptitude for understanding process technology and equipment, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with all levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
- The successful candidate will have a BA/BS plus a minimum of 8 years’ experience OR MBA/MS plus a minimum of 5 years experience in a science or engineering related field
- Manufacturing experience with demonstrated technical skills related to aseptic filling are highly desired
- Experience in a cGMP environment including specific knowledge of and experience with Drug Product processing and equipment is also desired.
Job will include standing, walking, and sitting. Occasional lifting may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Job is based upon a 1st shift schedule (8-430), but may require occasional off shift and weekend support.