Technical Writer

Job Title: Technical Writer

Location: Raleigh, NC (Onsite / Hybrid as required)

Team Mission

The Technical Writer will support capital project execution by ensuring all turnover documentation is complete, compliant, and audit-ready prior to commissioning. This role serves as a key documentation gatekeeper, receiving turnover packages , reviewing them for accuracy and compliance, coordinating with internal subject matter experts (SMEs), and driving final approval and archival before commissioning activities begin.

Key Responsibilities

• De-risk commissioning and CNQ by ensuring all turnover documentation is complete, compliant, audit-ready, and formally approved
• Reduce late-stage delays and rework by front-loading a rigorous, structured documentation review process
• Receive, track, and process turnover packages from Vendor
• Perform detailed reviews to validate completeness and accuracy of packages, including:
• Engineering drawings
• Certificates and test results
• Vendor documentation and manuals
• Construction and installation records
• Ensure all documentation meets quality standards, compliance requirements, and audit expectations
• Coordinate closely with vendors and SMEs to resolve documentation gaps, discrepancies, or deficiencies
• Manage approval workflows and final document versions
• Ensure no commissioning activities begin without all required turnover packages green-tagged and approved
• Maintain tight alignment with internal and vendor documentation and quality processes to avoid inconsistencies and rework

Required Qualifications

• Strong hands-on experience with engineering, construction, vendor documentation, and turnover packages
• Proven experience supporting capital projects in regulated environments
• Ability to review complex technical documentation for accuracy, completeness, and compliance
• Strong organizational skills and attention to detail with the ability to manage high documentation volumes

Preferred Qualifications

• Strongly preferred: Experience in pharmaceutical, biotech, or other highly regulated capital projects
• Experience using Meridian document management system (
• Experience with ACC, BIM 360, Aconex, or similar construction/document collaboration platforms
• Familiarity with commissioning, qualification, and validation (CQV) documentation workflows

Education & Experience

• Formal engineering degree not required with demonstrated, relevant experience
• 10 years of robust, applicable experience in documentation, turnover, or capital project support strongly preferred

Key Skills & Competencies

• Technical documentation review and approval
• Regulatory and audit readiness
• Cross-functional coordination with EPCs and internal stakeholders
• Risk mitigation and quality assurance
• Document control and lifecycle management