Technical Writer

Technical Writer - Onsite in Clayton, NC

This is a pharmaceutical technical writing position focused on developing, revising, and managing GMP documentation that supports manufacturing operations, process engineering, facilities, training, and quality systems. The role is not simply editing documents. The individual serves as a documentation SME and works closely with operations, engineering, learning & development, and quality teams to create and maintain compliant operational procedures and work instructions.

• Candidates must be able to work onsite.
• No 3rd party vendors
• Must be eligible to work in the Unite States.
• No Corp to Corp candidates please.

What the Person Will Be Doing

The primary responsibility is to create, revise, and manage operational documentation used within a pharmaceutical manufacturing environment, including:

• SOPs (Standard Operating Procedures)
• Work Instructions
• Job Instructions
• Training documents
• Controlled documents
• Change control documentation
• Quality management system (QMS) documents
• Process and operational standards
• Document revisions and remediation activities

The writer will also:

• Translate complex manufacturing and production-floor activities into clear written instructions.
• Work closely with SMEs and document owners.
• Support document change control processes.
• Review documents for compliance, readability, consistency, and accuracy.
• Manage document revisions through approval workflows.
• Support quality and operational improvement initiatives.
• Serve as an SOP and documentation subject matter expert.

Technical Environment

This role supports a pharmaceutical manufacturing site and requires understanding of:

• GMP requirements
• Manufacturing operations
• Production processes
• Documentation lifecycle management
• Change control systems
• Quality systems
• Training processes
• Lean/process improvement concepts

Major Requirements

Industry Experience

The strongest candidates will have:

• Pharmaceutical manufacturing experience
• Biotech experience
• GMP-regulated environment experience
• Technical writing experience supporting operations, engineering, manufacturing, facilities, or quality groups

Documentation Experience

Candidates should have experience authoring and managing:

• SOPs
• Work Instructions
• Job Instructions
• Quality documents
• Change controls
• Controlled documents
• Training documentation

Change Control Knowledge

The role specifically emphasizes:

• Document revision processes
• Change control systems
• Documentation management
• Managing multiple document revisions simultaneously
• Supporting active document change controls (DCCs)

Communication & Collaboration

Candidates must be comfortable:

• Interviewing SMEs
• Working with production personnel
• Partnering with Quality and Learning & Development teams
• Coaching document owners on writing standards
• Translating technical manufacturing activities into clear instructions

Ideal Candidate Profile

The ideal candidate is someone who has spent years in pharmaceutical manufacturing organizations supporting:

• Process Engineering
• Facilities Engineering
• Maintenance
• Manufacturing Operations
• Quality Systems

and has significant experience writing and revising:

• SOPs
• Maintenance procedures
• Calibration documents
• Equipment-related documentation
• Training materials
• Manufacturing work instructions
• while understanding GMP requirements and controlled document systems.