Technical Writer

JOIN THE TEAM THAT MAKES SMART MANUFACTURING HAPPEN

We’re passionate about helping manufacturing companies apply modern technologies to achieve their goals. We collaborate globally and cross-functionally to implement great solutions, and we still get excited every time we help a customer exceed their targets. Every one of us is an expert in our chosen field, but we are constantly learning and broadening our personal capabilities beyond our core skillset. We know when to ask for help, and there are always smart people on the team ready to help us solve complex problems or examine options with a fresh perspective.

Technical Writer – GxP Manufacturing:

We’re hiring a Contract Technical Writer to create and maintain GxP-compliant documentation for leading life sciences and manufacturing clients. You will work closely with subject matter experts (SMEs), quality assurance (QA), IT, and implementation teams to ensure clear, accurate, and audit-ready deliverables.

What You’ll Be Working On:

• Write and update Standard Operating Procedures (SOPs), Validation Protocols, Work Instructions, User Guides, and Technical Specifications to support GxP-compliant operations
• Support Computer System Validation (CSV) and software lifecycle documentation (URS, FRS, risk assessments, traceability matrices)
• Ensure compliance with current GxP regulations, internal quality systems and client-specific requirements
• Document processes for Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), and ERP in regulated environments
• Maintain document control in Veeva Vault, MasterControl, or Documentum
• Assist in training material creation and help maintain knowledge bases and wikis for internal and client use

What to Expect:

• Contract role with remote flexibility
• Fast-paced, collaborative environment
• Projects in pharma, biotech, and medical device industries
• Work on documentation that directly impacts compliance, quality, and operational excellence

What You Bring to the Table:

Required:

• Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related
• 3+ years technical writing in regulated manufacturing (pharma, biotech, med device) as a technical writer
• Strong understanding of GxP, and regulator frameworks (FDA 21 CFR Part 11, EU Annex 11, ICH Q9/Q10).
• Experience working with manufacturing systems such as MES, LIMS, ERP, or QMS platforms
• Excellent written English, grammar, and formatting skills
• Ability to collaborate cross-functionally and manage multiple deadlines in a fast-paced, client-facing environment

Preferred:

• GAMP 5 and CSV software validation documentation
• Familiarity with agile methodologies and tools such as Jira, Confluence or similar
• Knowledge of electronic records/signatures compliance

You’ll Love Working With Us:

• Competitive contract rates for specialized life sciences documentation skills
• Work with industry-leading experts in manufacturing and compliance
• Remote-friendly with flexible scheduling
• Contribute to audit-ready documentation that drives client success

Job Type: Contract

Pay: From $40.00 per hour

Expected hours: No less than 10 per week

Work Location: Remote