We are seeking a detail-oriented Technical Writer to support the development, revision, and management of manufacturing and engineering documentation within a GMP-regulated environment. This role will be responsible for converting complex engineering, validation, and technical documents into clear, compliant, and user-friendly Standard Operating Procedures (SOPs) and other controlled documentation.
The ideal candidate will have experience working in a regulated pharmaceutical, medical device, consumer health, or life sciences environment and possess strong document management skills using Microsoft Word and Adobe Acrobat. This position requires a significant on-site presence initially to build relationships with stakeholders, facilitate document reviews, and drive approvals and signatures through completion.
Key Responsibilities
- Review and interpret engineering, technical, validation, and operational documents.
- Transform technical content into clear, concise, and compliant SOPs, work instructions, and controlled documents.
- Collaborate with engineers, quality, validation, manufacturing, and cross-functional teams to gather and verify technical information.
- Ensure documentation aligns with GMP requirements, company standards, and document control procedures.
- Manage document review cycles, incorporating stakeholder feedback and maintaining version control.
- Coordinate approval workflows and actively facilitate the collection of required signatures and approvals.
- Maintain documentation accuracy, consistency, formatting, and traceability.
- Utilize Microsoft Word to develop and format professional documentation templates and final deliverables.
- Use Adobe Acrobat to review, edit, compile, and manage controlled PDF documentation.
- Support document archival, revision management, and document management system activities as required.
- Identify opportunities to improve documentation processes and standardization.
- Timing and Duration
- The Technical Writer is needed to start immediately to become familiar with the site's equipment, systems, processes, and key stakeholders.
Required Qualifications
- Bachelor's degree in Technical Writing, English, Communications, Engineering, Life Sciences, or a related field, or equivalent experience.
- 2-4 years of technical writing experience in a GMP-regulated environment.
- Experience creating and editing SOPs, work instructions, controlled documents, or quality system documentation.
- Proficiency in Microsoft Word, including advanced formatting, styles, templates, tables, and document controls.
- Proficiency in Adobe Acrobat for document editing, review, and PDF management.
- Strong attention to detail with excellent proofreading and editing capabilities.
- Ability to interpret technical and engineering information and translate it into end-user documentation.
- Strong organizational, communication, and stakeholder management skills.
Preferred Qualifications
- Experience supporting pharmaceutical, consumer health, biotechnology, medical device, or manufacturing operations.
- Familiarity with document management systems and controlled document workflows.
- Experience working with Quality, Validation, Engineering, or Manufacturing teams.
- Knowledge of GMP documentation practices, data integrity principles, and compliance requirements.
Work Arrangement
On-site in Fort Washington, PA during onboarding and initial engagement period to support stakeholder collaboration, document reviews, approvals, and signature collection.
Opportunity for a hybrid schedule (1-2 remote days per week) once the individual has established working relationships, gained familiarity with documentation processes, and can operate independently.