GMP Technical Writer: SOPs, Controls & Documentation

Sunrise Systems, Inc.; Fort Washington (Montgomery County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid schedule

On-site onboarding

Job summary

Sunrise Systems, Inc. is seeking a detail-oriented Technical Writer to support GMP-regulated manufacturing and engineering documentation.

The role focuses on converting complex engineering and validation documents into clear SOPs and controlled documents, leveraging Word and Acrobat to ensure accuracy and traceability. The ideal candidate has 2–4 years in GMP contexts, strong document management skills, and a willingness to work on-site initially with a path to hybrid work after onboarding.

Qualifications

• 2–4 years of technical writing in a GMP-regulated environment.
• Experience creating and editing SOPs, work instructions, 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.

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 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.

Skills

Technical writing

Microsoft Word

Adobe Acrobat

Stakeholder management

GMP compliance

Editing

Proofreading

Documentation control

End-user docs

Education

Bachelor's degree

Tools

Microsoft Word

Adobe Acrobat

Job description

Sunrise Systems, Inc. is seeking a detail-oriented Technical Writer to support GMP-regulated manufacturing and engineering documentation.

The role focuses on converting complex engineering and validation documents into clear SOPs and controlled documents, leveraging Word and Acrobat to ensure accuracy and traceability. The ideal candidate has 2–4 years in GMP contexts, strong document management skills, and a willingness to work on-site initially with a path to hybrid work after onboarding.