Technical Writer

Planet Pharma; Clayton (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Planet Pharma onsite in Clayton, NC seeks a pharmaceutical technical writer to create, revise, and manage GMP documentation supporting manufacturing operations, process engineering, facilities, training, and quality systems.

This role goes beyond editing; you will translate complex production activities into clear written instructions, author SOPs, work instructions, and controlled documents, and work with SMEs to ensure accuracy and compliance.

Qualifications

• Pharmaceutical manufacturing experience preferred.
• Experience supporting GMP-regulated documentation.
• Experience authoring and managing SOPs, Work Instructions, and quality documents.

Responsibilities

• Create, revise, and manage operational documentation for pharmaceutical manufacturing.
• Translate complex manufacturing activities into clear written instructions.
• Review documents for compliance, readability, and accuracy.
• Manage document revisions through approval workflows.
• Collaborate with SMEs, QA, and Learning & Development.
• Coach document owners on writing standards.

Skills

Technical writing

SOPs

Documentation management

Change control systems

SME collaboration

Editing not enough

Job description

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.
• 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
• Controlled documents
• 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.
• 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
• Change control systems
• Quality systems
• Training processes
• Lean/process improvement concepts

Major Requirements

Industry Experience

The strongest candidates will have:

• Pharmaceutical manufacturing 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

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)

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
• Maintenance
• Manufacturing Operations
• Quality Systems

and has significant experience writing and revising:

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