Technical Writer

Catalent•Morrisville, NC

23h•Onsite

About The Position

Technical Writer Position Summary: Work Schedule: Monday - Friday, 8:00am to 4:30pm 100% on-site The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to-end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. The Technical Writer supports the manufacture of Phase 1, 2, and 3 for clinical supplies and commercial supplies working closely with quality and operations management.

Requirements

Must have Bachelors Degree and minimum of 1 year related experience OR Associates Degree and minimum of 3 years related experience OR Equivalent combination of relevant education, experience and training will be considered in lieu of Associates and Bachelors degree.
Must have proficiency in MS Office
Ability to read, understand, and interpret technical instructions and technical writing is required

Nice To Haves

Previous clinical and commercial operations experience is preferred
Prior direct experience with manufacturing operations - Cleaning, Compounding, Filling, Inspection and Assembly Operations is preferred

Responsibilities

Perform investigations; write problem reports prior to QA review; write and complete CAPAs, deviations and change controls; interact with customers as needed
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
Compile and maintain metrics related to operations
Provide training to management and production personnel to promote well- written, thorough investigation reports; Assist in the training of operations technicians
Other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference.
personal initiative. dynamic pace. meaningful work.