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Technical Writer Intern - Morrisville North Carolina
Company: Disability Solutions Location: Morrisville, North Carolina
Posted On: 02/06/2025
Technical Writer InternPosition Summary:Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.--Catalent Pharma Solutions is Morrisville, NC is hiring a Technical Writer Intern who will help support Quality and Operations Management regarding the manufacturing of clinical and commercial supplies during Phase 1, 2, and 3.-- The Production Department is responsible for the production of Dry Powder Inhalers and Non-Sterile Liquids within Catalent, Morrisville, North Carolina. This includes setup, operation, changeover, and routine maintenance of automated and manual equipment. The Production Department executes, completes, and reviews all associated master batch record documentation; creates and reviews standard operating procedures; creates manufacturing metrics documentation and assists with process development and validation studies.This is an hourly internship role. This is onsite working 20-40 hours a week.-- The core hours are Monday - Friday 8:00AM -4:30PM.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: - Create and revise standard operating procedures for production; revisions may be related to process improvements, customer requests and/or audit observations; create and revise procedures for new equipment and batch manufacturing;
- Revise master batch records including interacting with other departments and customers as necessary; Assemble batch related documentation and complete reviews prior to transfer to quality assurance; Develops proper documentation for batch production;
- Interact with quality assurance and other functional areas to ensure timely closure of designated batch release investigations; Interact with production personnel on continuous improvement projects related to procedures, batch records, or other assignments;
- Work with engineering to develop equipment process parameters and process workflow for new manufacturing processes;
- All other duties as assignedThe Candidate:
- Current or recent enrollment in an undergraduate or graduate degree program (e.g. Science or Engineering) required;
- Proficient in Microsoft Word, Excel, and Adobe Professional required;
- Must be located within 50 miles of the Morrisville, North Carolina site during internship to be considered;
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
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