Technical Writer

Catalent • Miller Township, IN

5d • Onsite

About The Position

Technical Writer Position Summary: Work Schedule: M-F 1st shift 100% on-site Greendale is one of two gummy technology development and manufacturing facilities in North America. The site has the capability to manufacture traditional gelatin gummies as well as 100% plant-based pectin gummies for nutritional supplements and nutraceuticals. With extensive development and manufacturing expertise and a wide range of flavors, shapes, sizes, and colors available, we can work with complex ingredients to help create engaging new products consumers will love. Catalent Pharma Solutions in Greendale, IN is hiring a Technical Writer. The Technical Writer is responsible for creating, reviewing, and maintaining accurate and compliant documentation to support GMP manufacturing, technical services, and quality operations. This role ensures all documents meet regulatory requirements, internal SOPs, and customer expectations.

Requirements

• High School Diploma/GED with 3+ years of progressive Technical Writing experience OR Bachelor’s degree in Science, Engineering, or related field (preferred).
• Familiarity with GMP documentation and change control processes.
• Prior experience in technical writing within a regulated environment (pharmaceutical or nutraceutical preferred).
• Knowledge of TrackWise or similar Change Management systems.
• Experience with electronic document management systems.
• Understanding of equipment qualification documentation (FAT/SAT/IOQ/PQ).
• Strong written and verbal communication skills in English.
• Strong proficiency in Microsoft Office Suite (Word, Outlook) and document management systems.
• Ability to interpret technical information and present it clearly.
• Detail-oriented with strong organizational and multitasking abilities.

Responsibilities

• Author, revise, and maintain Master Batch Records, SOPs, protocols, and related technical documents.
• Ensure documentation complies with cGMP, FDA regulations, and Catalent standards.
• Collaborate with cross-functional teams (Quality, Operations, Engineering) to gather technical information and ensure accuracy.
• Assist with document lifecycle, including approval routing, version control, and archiving.
• Track and complete corrective actions related to documentation deviations and change controls in the TrackWise system.
• All other duties as assigned

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of paid time off + 8 paid holidays
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees