Technical Writer
Listed on 2026-09-22
-
Business
Regulatory Compliance Specialist
Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs.
Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.
We have an opportunity for a Technical Writer. This position is responsible for collecting, organizing, formatting and authoring documents. This role will make inputs into the site inventory management system for Manufacturing activities.
Shift: Monday
- Friday 8:00am-5:00pm
Location:
Greenville, NC
100% Onsite
- Work with Subject Matter Expert (SME) to gather the information needed to create new 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 manufacturing events
- Responsible to close out help desk tickets regarding 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
- Coordinate document approval across the organization
- Provide lean and agile response to changing priorities in service of multiple business units for both packaging and manufacturing activities
- Other duties as assigned
Minimum Requirements
- Requires Bachelor’s degree in a STEM-related field with at least 1 year of relevant experience; OR
- Requires Associate degree in a STEM-related field with at least 2 years of relevant experience; OR
- Requires High school diploma or equivalent with at least 3 years of relevant industry experience
- Ability to administer quality system programs and resources
- Familiar with GMP documentation requirements
- Proficient with computer systems such as Microsoft Office Word, Excel and Adobe Professional and database management software
- Effective presentation/communication skills, project/resource management skills
- 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
- Strongly prefer at least one year of technical writing experience
- Positive and fast-paced working environment focusing on continual improvement and innovation.
- Competitive Paid Time Off plus 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement to help you finish…
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