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Catalent · 5 hours ago

Technical Writer

Greendale, IN

Full-time

Onsite

Mid Level

3+ years exp

Catalent is a leading global drug development and delivery company, and they are seeking a Technical Writer. The Technical Writer will be responsible for creating and maintaining documentation to support GMP manufacturing and quality operations, ensuring compliance with regulatory requirements.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

GMP DocumentationTrackWiseTechnical WritingElectronic Document ManagementEquipment Qualification DocumentationMicrosoft Office SuiteCommunication SkillsDetail-orientedOrganizational Skills

Required

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

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

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2022 (1)