Technical Writer
Catalent Pharma Solutions
Summary
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.
Job description
The Role
- 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
Preferred Skill and Background
- Strongly prefer at least one year of technical writing experience
Requirements
- Bachelor's degree in a STEM-related field with at least 1 year of relevant experience; OR
- Associate degree in a STEM-related field with at least 2 years of relevant experience; OR
- 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
Benefits
- Paid Time Off
- 8 Paid Holidays
- Medical, Dental & Vision
- Tuition Reimbursement
- WellHub Wellness Program
- Onsite Fitness Center
- Employee Discounts
- Employee Resource Groups
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.