Technical Writer
LanceSoft Inc
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
Job Requirements:
Packaging Development / Technical Protocols
- Technical Documentation : Experience with PDP (Packaging Development Protocols), GMP documentation, and execution documents using scripted templates.
- Industry Background : Prior experience working in a GMP-regulated environment, preferably within the OTC or pharmaceutical industry.
- Experience : 3–7 years of relevant industry experience.
- Packaging Operations : Experience in packaging operations, including familiarity with batch records and a strong understanding of packaging processes(Advantage)
- Work Arrangement : Onsite role with some flexibility.
- Availability : Candidates who can join immediately are preferred.
- Candidate Preference : Relevant hands-on experience and practical process knowledge will be prioritized over formal educational qualifications.
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.
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