Technical Writer I Process Development

Technical Writer I Process Development

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

Catalents 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 102700-square-foot GMP facility specializes in mammalian cell line engineering drug substance manufacturing and biopharmaceutical process development.

The site is home to Catalents 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 4000L and a recent $45 million expansion the Madison campus continues to play a critical role in Catalents global biologics network while supporting Wisconsins growing life sciences industry.

Location: 100% Onsite at our facility in Madison Wisconsin

Shift: Monday Friday First Shift

Key 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.

Required Qualifications

• Bachelors degree in a STEM discipline with a minimum of 1 year of relevant experience or an associates 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.

Preferred Qualifications

• 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.

Why you should join Catalent

• Opportunity to play a key role in driving growth within a global CDMO leader.

• Competitive compensation package including incentive opportunity.

• Day-one medical dental and vision coverage.

• 401(k) with company match.

• Tuition reimbursement and professional development opportunities.

• Generous paid time off and holiday schedule (152 hours 8 holidays)

• Collaborative mission-driven culture focused on improving patient outcomes worldwide.