The Technical Writer is responsible for developing, editing, and maintaining Packaging Development documentation, including Package Development Reports (PDRs), Package Development Assessment Plans (PDAPs), validation documentation, technical assessments, specifications, and supporting reports. This role partners with Packaging Development, Technical Operations, Quality Assurance, Manufacturing, Regulatory Affairs, R&D, and external suppliers to collect, organize, and communicate technical information in a clear, compliant, and traceable manner.
Key Responsibilities:
Author and maintain PDRs, PDAPs, technical assessments, validation reports, and related documentation.
Coordinate cross-functional reviews and approvals.
Consolidate technical data into compliant documentation.
Support change controls, CAPAs, and audit activities.
Develop templates, SOPs, and work instructions.
Ensure documentation complies with GMP, GDP, and quality standards.
Qualifications:
Bachelor's degree in Technical Writing, Packaging Science, Engineering, Life Sciences, Communications, or related field. 3-7 years of technical writing experience in a regulated industry preferred.
Preferred Qualifications:
Experience in pharmaceutical, medical device, consumer healthcare, or packaging development environments. Familiarity with TrackWise, Veeva, SAP, or other document management systems.
Key Competencies:
Technical writing, document control, attention to detail, project coordination, cross-functional collaboration, analytical thinking, and regulatory compliance.
Success Measures:
On-time document completion, audit readiness, documentation accuracy, reduced revision cycles, and effective stakeholder support.
