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 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. 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 • 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. 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. 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 . Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.