Job Title: Technical Writer GMP & Engineering Documentation
Location: Fort Washington, PA
Shift/Hours: Monday Friday, 8:30 AM 5:00 PM
Engagement Type: Contract (12 Months | Oct 2026 Oct 2027)
Position Overview
We are seeking a detail-oriented Technical Writer to support the creation, revision, and lifecycle management of manufacturing and engineering documentation in a GMP-regulated environment. In this role, you will interface directly with engineering, quality, validation, and manufacturing teams to translate complex technical documents into clear, compliant Standard Operating Procedures (SOPs), Work Instructions, and controlled documents.
Key Responsibilities
- Content Conversion & Authoring: Review and interpret complex technical, validation, engineering, and operational documents; translate them into compliant, easy-to-follow SOPs, Work Instructions, and controlled documentation.
- Stakeholder Collaboration: Partner with engineers, validation leads, quality assurance, and manufacturing SMEs to verify technical processes and extract key procedural details.
- Workflow & Approvals Management: Drive the end-to-end document lifecycle-manage review cycles, track feedback, maintain strict version control, and expedite cross-functional sign-offs/approvals.
- Compliance & Standards: Ensure all documentation adheres to current GMP regulations, site data integrity principles, and document control procedures.
- Template & PDF Management: Leverage advanced MS Word features (styles, templates, tables, document controls) to produce standardized deliverables; use Adobe Acrobat to manage and compile controlled PDF documentation packages.
- Continuous Improvement: Identify standardization gaps and optimize documentation procedures for operational readiness.
Required Qualifications
- Education: Bachelor's degree in Technical Writing, English, Communications, Engineering, Life Sciences, or equivalent practical experience.
- Experience: 2 4+ years of technical writing experience within a GMP-regulated environment (Pharma, Biotech, Medical Device, or Consumer Health).
- Core Documentation Expertise: Proven track record authoring and editing SOPs, Work Instructions, and controlled quality system documentation.
- Technical Software Skills: Advanced proficiency in Microsoft Word (templates, styles, formatting controls) and Adobe Acrobat (PDF assembly, form fields, review tools).
- Execution & Communication: Strong stakeholder engagement skills with the ability to chase approvals and drive documentation milestones through completion.
Preferred Qualifications
- Prior experience interfacing with Validation (IQ/OQ/PQ), Quality, and Manufacturing teams.
- Hands-on familiarity with Document Management Systems (EDMS/QMS like Veeva, Documentum, MasterControl, etc.).
- Working knowledge of data integrity principles (ALCOA+) and regulatory document control.
Work Arrangement & Schedule
- Initial Phase: Primarily on-site in Fort Washington, PA to facilitate stakeholder alignment, system walkthroughs, and approval workflows.
Thanks
Sri Vardhan Chilakamukku
Infobahn SoftWorld Inc.