More jobs:
Technical Writer
Job in
Raleigh, Wake County, North Carolina, 27601, USA
Listed on 2026-01-27
Listing for:
Technical Source
Full Time
position Listed on 2026-01-27
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist / Manager, Quality Engineering
Job Description & How to Apply Below
Job Title: Technical Writer
Location: Raleigh, NC (Onsite / Hybrid as required)
Base pay range: $60,000.00/yr - $/yr
Team MissionThe 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 vendors
- Perform detailed reviews to validate completeness and accuracy of packages, including:
- 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
- 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
- Strongly preferred: Experience in pharmaceutical, biotech, or other highly regulated capital projects
- Experience with ACC
, BIM 360, Aconex, or similar construction/document collaboration platforms - Familiarity with commissioning, qualification, and validation (CQV) documentation workflows
- Formal engineering degree not required with demonstrated, relevant experience
- 10+ years of robust, applicable experience in documentation, turnover, or capital project support strongly preferred
- 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
- Associate
- Full‑time
- Writing/Editing
- Pharmaceutical Manufacturing and Construction
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