Technical Writer- SOP for MES Program

Role: Technical Writer- SOP for MES Program

Location: Summit NJ , Remote 

Duration: 3 Months+

Key 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).

Required Qualifications

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