Confidential · 22 hours ago
Packaging Technical Writer
Confidential is seeking a Packaging Technical Writer to support documentation, process improvement, and compliance activities within a pharmaceutical packaging environment. This role focuses on preparing, reviewing, and maintaining technical documentation in accordance with cGMP and FDA guidelines, while collaborating closely with packaging, quality, and manufacturing teams.
Responsibilities
Prepare, review, and revise technical documentation including batch records, specifications, methods, COAs, validation protocols, and reports
Support packaging investigations, CAPAs, change controls, and deviation documentation
Conduct focused time studies to support packaging operations and efficiency
Apply lean and process improvement tools (5S, Fishbone, Kanban, poka-yoke, visual controls)
Review documents for accuracy, clarity, compliance, and correct terminology
Perform data analysis and provide recommendations to improve packaging operations
Follow SOPs for document creation, control, and storage
Participate in root cause analysis and continuous improvement initiatives
Ensure compliance with safety, health, and environmental procedures
Collaborate cross-functionally while also working independently when required
Support administrative and project-related tasks as assigned
Qualification
Required
BA/BS degree in a related field from an accredited institution
1–3 years of technical writing experience
Strong understanding of cGMPs and FDA guidelines
Excellent written and verbal communication skills in English
Strong proficiency in Microsoft Word, Excel, PowerPoint, and PDF editing tools
High attention to detail and strong documentation control skills
Ability to manage multiple priorities and meet deadlines
Candidates must be authorized to work in the United States
Preferred
Experience in a pharmaceutical or regulated manufacturing environment
Benefits
Health, Dental & Vision Insurance
401(k) with company match
Paid Time Off & Holidays
Short- and Long-Term Disability
Parental & family leave
Company
Confidential
Funding
Current Stage
Late StageCompany data provided by crunchbase