Technical Writer

Lancesoft

Fort Washington (Montgomery County)

Hybrid

USD 70,000 - 90,000

Full time

6 days ago
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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

Job Title

Technical Writer

Location

Fort Washington PA 19034

Duration

10/19/2026 to 10/15/2027

Hybrid schedule

3 days remotely and 2 days on site

Description

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
  • Regulatory compliance
Success Measures
  • On-time document completion
  • Audit readiness
  • Documentation accuracy
  • Reduced revision cycles
  • Effective stakeholder support
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Medical insurance
401(k)
Vision insurance