GMP-Driven Packaging Documentation Specialist

Us Tech Solutions; Fort Washington (Montgomery County); On-site; USD 60,000 - 85,000; Full time

Job summary

US Tech Solutions is seeking a Technical Writer to develop, edit, and maintain Packaging Development documentation, including PDRs, PDAPs, validation docs, specifications, and supporting reports. The role partners with Packaging Development, Technical Operations, QA, Manufacturing, Regulatory Affairs, R&D, and external suppliers to communicate technical information clearly, compliantly, and traceably.

You will author and maintain PDRs/PDAPs, coordinate cross-functional reviews, consolidate data

Qualifications

• Bachelor's degree in a technical field and 3–7 years of technical writing experience in a regulated industry preferred.
• Strong ability to produce compliant, traceable documentation in GMP/GDP environments.

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.

Skills

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Technical Writing, Packaging Science, Engineering, Life Sciences, Communications, or related field

Tools

TrackWise

Veeva

SAP

Job description

US Tech Solutions is seeking a Technical Writer to develop, edit, and maintain Packaging Development documentation, including PDRs, PDAPs, validation docs, specifications, and supporting reports. The role partners with Packaging Development, Technical Operations, QA, Manufacturing, Regulatory Affairs, R&D, and external suppliers to communicate technical information clearly, compliantly, and traceably.

You will author and maintain PDRs/PDAPs, coordinate cross-functional reviews, consolidate data