Technical Writer

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing organization to identify a Technical Writer to support documentation and compliance efforts within a GMP-regulated environment. This individual will play a key role in developing, editing, and maintaining critical documentation to support quality, validation, and manufacturing operations. The ideal candidate will have experience working cross-functionally in a fast-paced, highly regulated setting and will be comfortable translating technical processes into clear, compliant documentation.

Responsibilities

• Develop, edit, and maintain technical documentation including SOPs, work instructions, validation protocols, and reports
• Collaborate with Quality, Manufacturing, and Engineering teams to ensure documentation aligns with GMP standards and operational processes
• Support documentation related to validation activities, including process, equipment, and cleaning validation
• Ensure all documentation meets regulatory requirements (FDA, cGMP) and internal quality standards
• Assist with document control processes, including versioning, change controls, and approvals
• Review existing documentation for accuracy, clarity, and compliance; recommend and implement improvements
• Support audit readiness efforts and assist during internal and external inspections as needed
• Translate complex technical information into clear, concise, and user-friendly documentation for various audiences

Requirements

• Bachelor’s degree in a scientific, technical, or related field (or equivalent experience)
• 4+ years of experience in technical writing within a GMP-regulated environment (pharma, biotech, or similar)
• Experience writing and editing SOPs, validation documentation, and/or quality-related documents
• Strong understanding of cGMP regulations and documentation practices
• Excellent written and verbal communication skills with strong attention to detail
• Ability to work cross-functionally and manage multiple priorities in a fast-paced environment
• Proficiency in Microsoft Office and document management systems