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Technical Transfer Engineer - Morrisville North Carolina
Company: Disability Solutions
Location: Morrisville, North Carolina
Posted On: 11/17/2024
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
- 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
- Identify process deficiencies and recommend corrective improvements
- All other duties as assigned;The Candidate
- High School Diploma or GED required, Associates Degree or Bachelors Degree is strongly preferred
- One or more years of related experience required with a Bachelors Degree, two or more years of related experience required with an Associates Degree, or eight or more years of related experience required with a High School Diploma or GED
- Prior experience working with Nasal Pharmaceutical Manufacturing Operations, Dry Powder Inhalation Processes, and Sterile Operations is strongly preferred
- Experience with manufacturing operations including Cleaning, Compounding, Filling, Inspection and Assembly Operations is preferred
- Experience in Clinical and Commercial Operations preferred
- Knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations, and industry trends is strongly preferred
- Experience working in an FDA-regulated industry and knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirements is preferred
- On an average eight-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below the waist height, climb or balance, stoop, kneel, crouch or crawl; talk, hear and smell, and lift up to 40 pounds.Why you should join Catalent:
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