Catalent
Overview
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.
The Role
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.
The Candidate
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.
Why you should join Catalent
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of paid time off and 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
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.
Technical Writer
The Role covers creating, reviewing and maintaining accurate and compliant documentation to support GMP manufacturing, technical services and quality operations. All documents meet regulatory requirements, internal SOPs and customer expectations.
Key Skills
Proofreading
Adobe Acrobat
Content Management Systems
Technical Writing
Visio
Microsoft PowerPoint
SharePoint
XML
Confluence/Wiki Systems
Word Processing
Writing Skills
Employment Type:
Full-Time
Experience:
years
Vacancy:
1
Catalent is an Equal Opportunity Employer including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email and confirming your request for an accommodation and include the job number, title and location. This option is reserved for individuals who require accommodation due to a disability.
Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency or search firm without a valid written and signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide payment, bank details, photocopies of identification, social security numbers or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request, DO NOT respond. Please forward such requests for investigation with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
#J-18808-Ljbffr
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.
The Role
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.
The Candidate
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.
Why you should join Catalent
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of paid time off and 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
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.
Technical Writer
The Role covers creating, reviewing and maintaining accurate and compliant documentation to support GMP manufacturing, technical services and quality operations. All documents meet regulatory requirements, internal SOPs and customer expectations.
Key Skills
Proofreading
Adobe Acrobat
Content Management Systems
Technical Writing
Visio
Microsoft PowerPoint
SharePoint
XML
Confluence/Wiki Systems
Word Processing
Writing Skills
Employment Type:
Full-Time
Experience:
years
Vacancy:
1
Catalent is an Equal Opportunity Employer including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email and confirming your request for an accommodation and include the job number, title and location. This option is reserved for individuals who require accommodation due to a disability.
Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency or search firm without a valid written and signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide payment, bank details, photocopies of identification, social security numbers or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request, DO NOT respond. Please forward such requests for investigation with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
#J-18808-Ljbffr