Technical Writer at CATALENT CTS SINGAPORE PRIVATE LIMITED

Miller Township, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

0.0

Posted On

02 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Writing, GMP Documentation, Change Control Processes, Regulated Environment Experience, TrackWise, Electronic Document Management Systems, Equipment Qualification Documentation, Strong Communication Skills, Microsoft Office Suite, Detail-Oriented, Organizational Skills, Multitasking Abilities

Industry

Pharmaceutical Manufacturing

Description

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 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 + 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 7,000 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

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Responsibilities

The Technical Writer is responsible for creating, reviewing, and maintaining accurate documentation to support GMP manufacturing and quality operations. This includes authoring Master Batch Records, SOPs, and ensuring compliance with regulatory requirements.