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Technology Transfer Engineer - Morrisville North Carolina
Company: Disability Solutions Location: Morrisville, North Carolina
Posted On: 05/09/2024
Position Summary:Catalent Pharma Solutions in Morrisville, NC is hiring a Technology Transfer Engineer for the Production group. The Production Group is responsible for the production of Nasal Inhalers, Dry Powder Inhalers, Tableting Operations, and Non-Sterile Liquids within the Catalent Morrisville site. The Technology Transfer Engineer supports the manufacturing of Phase 1, 2, and 3 for clinical supplies and commercial supplies, and works closely with Quality, Operations, and Product Development management.This is a full-time position: Monday - Friday, 8:00AM - 5:00PM.Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.----Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role - Perform investigations, write problem reports prior to QA review, write and complete CAPAs, deviations, and change controls, and interact with customers as needed
- Create and revise standard operating procedures for production, as well as create and revise procedures for new equipment and batch manufacturing
- Create and revise master batch records, and assemble batch related documentation and complete reviews prior to transfer to quality assurance
- Assist in the NPI process for the technical transfer of new products/processes into the production facility, and act as the point-person for manufacturing on cross-functional NPI teams
- Work with Product Development to develop process knowledge for new processes as it relates to manufacturing and technical operations
- Work with engineering to develop equipment process parameters and process workflow for new manufacturing processes
- Assist in the creation of work instructions and job aids, and train manufacturing operators on the execution of new manufacturing processes as it relates to batch record documentation and process workflow
- Assist engineering to develop manufacturing equipment improvements, quality improvements, and line performance improvements;
- Identify process deficiencies and recommend corrective improvements
- All other duties as assigned;The Candidate
- Associates Degree is requires, Bachelors Degree is strongly preferred
- 3 or more years of related experience with a Bachelors Degree, or 5 or more years of related experience with an Associates Degree
- Prior experience required working with Nasal Pharmaceutical Manufacturing Operations, Dry Powder Inhalation Processes, and Sterile Operations
- Experienced with Tablet Operations including: Dispensing, Compression, Coating, and Encapsulation
- Strong written and verbal communication skills
- Working knowledge of cGMPS
- Strong analytical reasoning skills, as well as root cause analysis and problem solving
- Able to write, read, understand, and interpret technical instructions
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
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