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Technical Writer
16 hours ago
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
