Technical Writer

Greendale, WI - USA

Monthly Salary: Not Disclosed

Posted on: 5 days ago

Vacancies: 1 Vacancy

Job Summary

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.

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 Bachelors 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 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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 to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position 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 any type of payment bank details photocopies of identification social security number 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 it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Technical WriterPosition Summary:Work Schedule: M-F 1st shift 100% on-siteGreendale 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 nutritio...