Technical Writer jobs in United States
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GlobalPoint · 4 hours ago

Technical Writer

positionUnited States
timeFull-time
remoteRemote
seniorityMid, Senior Level
date2+ years exp

GlobalPoint is seeking a Technical Writer to create and maintain documentation for manufacturing processes. The role involves collaborating with Subject Matter Experts to ensure compliance with regulatory standards and managing document lifecycles using an Electronic Document Management System.

ConsultingOutsourcing
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Documentation Development: Create, edit, and maintain clear, step-by-step SOPs and Electronic Batch Record (eBR) instructions based on functional specifications and user requirements
SME Collaboration: Work closely with Subject Matter Experts (SMEs)—including manufacturing, automation engineers, quality assurance, and IT—to gather accurate process information
GxP/Regulatory Compliance: Ensure all procedures comply with FDA, EMA, and GxP standards, focusing on data integrity, electronic signatures, and validation requirements
MES System Integration: Translate physical manufacturing processes into digital workflows within the MES, ensuring that system prompts are intuitive and compliant
Version Control & Document Life Cycle: Manage the review, approval, and lifecycle of documents using an Electronic Document Management System (EDMS)

Qualification

Manufacturing Execution Systems (MES)GxP ComplianceTechnical WritingElectronic Document Management System (EDMS)Regulatory KnowledgeAttention to Detail

Required

2–5+ years of technical writing experience for MES within a GxP environment
Direct experience with Manufacturing Execution Systems (MES) (e.g., Emerson Syncade, Rockwell, Werum PAS-X) and EDMS platforms (e.g., Aveva)
Strong understanding of 21 CFR Part 11, 210, 211, and GMP compliance
Exceptional, clear, and concise technical writing skills with meticulous attention to detail

Company

GlobalPoint

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GlobalPoint is a consulting, technology and outsourcing services company.
dateFounded in 2006
location
North Brunswick, New Jersey, USA
people-size201-500 employees
web-link
http://www.globalpointinc.com/

H1B Sponsorship

GlobalPoint has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (46)
2023 (60)
2022 (33)
2021 (33)
2020 (50)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase