Technical Writer I - Process Development

Catalent Pharma Solutions•Madison, WI

6d•Onsite

About The Position

Catalent is seeking a Technical Writer I – Process Development to join our growing Technical Writing team supporting biologics development and manufacturing programs at our Madison, Wisconsin site. This role is responsible for authoring, reviewing, and maintaining critical scientific and manufacturing documentation, including development reports, protocols, and client-facing technical documents. The successful candidate will combine strong written communication skills, attention to detail, scientific understanding, and cross-functional collaboration to ensure the delivery of accurate, high-quality documentation supporting client programs and internal operations. About Catalent Madison Catalent's Madison, Wisconsin facility is a state-of-the-art biologics development and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development. The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologics network while supporting Wisconsin's growing life sciences industry.

Requirements

Bachelor's degree in a STEM discipline with a minimum of 1 year of relevant experience, or an associate's degree in a STEM discipline with a minimum of 4 years of relevant experience.
Strong written communication, editing, proofreading, and organizational skills.
Exceptional attention to detail with the ability to identify inaccuracies, inconsistencies, and documentation errors.
Ability to effectively seek clarification, collaborate with cross-functional teams, and communicate professionally with stakeholders.
Comfort working in a documentation-focused, desk-based environment supporting scientific and manufacturing operations.
Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.

Nice To Haves

Degree in Biology, Biotechnology, Biochemistry, Microbiology, or another Life Sciences discipline.
Previous technical writing, scientific writing, editing, documentation, or reporting experience.
Experience working within biotechnology, pharmaceutical, manufacturing, laboratory, or other regulated environments.
Knowledge of GMP documentation practices and quality systems.
Experience reviewing scientific, technical, or manufacturing documents for accuracy and completeness.
Experience supporting client-facing documentation or professional written correspondence.

Responsibilities

Author, edit, and maintain technical reports, protocols, certificates of testing, and other scientific documentation supporting Cell Line Development (CLD), Process Development (PD), and manufacturing activities.
Review documents for accuracy, consistency, completeness, formatting, and compliance with applicable quality and documentation standards.
Collaborate with scientists, manufacturing personnel, quality teams, and subject matter experts to gather information and resolve documentation questions.
Identify and escalate discrepancies, inconsistencies, or potential errors to ensure accurate reporting and minimize downstream impacts.
Support preparation of client-facing technical reports and maintain clear, professional written communication with internal and external stakeholders.
Manage multiple documentation projects simultaneously while meeting established timelines and deliverables.
Assist with continuous improvement initiatives related to documentation processes, templates, and workflows.
Maintain compliance with GMP documentation practices and data integrity requirements.
Other responsibilities as needed.