We are looking for a Nebulizer Process Specialist to join the growing Phase III team. The incumbent will be responsible for the manufacturing of sterile liquids for commercial distribution and clinical trials. The Nebulizer Process Specialist will be responsible for the teaching setup, and troubleshooting, operation when needed of all pharmaceutical manufacturing/packaging equipment including; Rommelag Blow Fill Seal machine, filtration vessel, deflashing/punching equipment, and other machines in the Nebulizer area. Personnel in this position will operate manufacturing processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Personnel in this position will provide support in inspection and packaging areas as required.
- Follow written procedures.
- Write and update procedures.
- Provide assistance and training to other operators on equipment and BPRs.
- Troubleshooting of equipment.
- Clearly and accurately document activities.
- Perform math calculations and assist other operators.
- Responsible to ensure that the product meets specifications.
- Increase efficiencies in the manufacturing processes.
- Attain and maintain Aseptic Gown Certification.
- Write clear concise observational memo and assist in investigation.
- Read, understand and review SOP’s and Protocols as required.
- BS degree required
- Minimum of 5 Years of experience in cGMP/Aseptic Operations Background
- Minimum of 3 years of pharmaceutical Blow Fill Seal (BFS) experience