Hybrid Technical Writer for GMP Packaging Docs

Lancesoft; Fort Washington (Montgomery County); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Lancesoft in Fort Washington, PA, seeks a Technical Writer to develop, edit, and maintain Packaging Development documentation, including PDRs, PDAPs, validation docs, specs, and supporting reports.

You will partner with Packaging Development, Technical Operations, QA, Manufacturing, Regulatory Affairs, R&D, and suppliers to collect and communicate technical information in a compliant, traceable manner, ensuring on-time delivery and audit readiness.

Qualifications

• Bachelor's degree in a relevant field.
• 3–7 years of technical writing experience in a regulated industry.
• Experience with GMP/GDP documentation standards.
• Familiarity with document management systems.

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

Document control

Cross-functional collaboration

Regulatory compliance

Attention to detail

Project coordination

Education

Bachelor's degree in Technical Writing, Packaging Science, Engineering, Life Sciences

Tools

TrackWise

Veeva

SAP

Job description

Lancesoft in Fort Washington, PA, seeks a Technical Writer to develop, edit, and maintain Packaging Development documentation, including PDRs, PDAPs, validation docs, specs, and supporting reports.

You will partner with Packaging Development, Technical Operations, QA, Manufacturing, Regulatory Affairs, R&D, and suppliers to collect and communicate technical information in a compliant, traceable manner, ensuring on-time delivery and audit readiness.