Technical Writer

Catalent

2d•Onsite

About The Position

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. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. 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 Technical Writer is responsible for collecting, organizing, formatting and authoring documents. The Technical Writer will make inputs into the site inventory management system for Manufacturing activities. This position is 100% on-site at the Greenville site.

Requirements

Bachelor’s degree in a Science-related field, Engineering or Industrial Technologies with at least 1 year of relevant experience preferred; previous technical writing experience preferred or;
Associate degree in a Science-related field, Engineering or Industrial Technologies with at least 2 years of relevant experience preferred; previous technical writing experience preferred or;
High school diploma or equivalent with at least 3 years of relevant industry experience; previous technical report writing preferred.
Ability to administer quality system programs and resources.
Familiar with GMP documentation requirements.
Experience with database management software.
Position requires the ability to occasionally lift 40 lbs unassisted, and occasionally push and pull a maximum of 100 lbs.
Majority of workday is performed while sitting, standing, and walking.
Requires the use of hands for simple grasping and fine manipulations..
Ability to climb, bend, stoop, twist, and have full range of motion in upper and lower extremities.
Occasional exposure to dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments.

Responsibilities

Work with Subject Matter Expert (SME) to gather the information needed to create new Technical Services documents or updates of existing documents (i.e. Master Batch Records and protocols) and coordinate associated change control documents.
Review documents with SME and Operations personnel to ensure they are accurate, executable and the formatting is consistent and harmonized.
Ensure the documentation database is accurate and inputs conform to company standards.
Ensure and assist in making inputs to the Manufacturing Resource Planning in preparation for Technical Services manufacturing events.
Responsible to close out Technical Service help desk tickets regarding Technical Service document corrections and updates.
Provide requested information during client and FDA audits.
Participate and contribute to the activities of the cross functional project development teams.
Participate and contribute to the continued implementation of electronic document software system.
All other duties as assigned.