Senior C&Q Documentation Engineer (W2)

Key Requirements

• Strong expertise in creating technical documentation from the ground up, including experience developing C&Q-related change controls (CLIAs) and working with URS documentation
• Hands-on experience within GMP-regulated pharmaceutical manufacturing environments
• Proven ability to collaborate cross-functionally and communicate effectively with internal teams
• Experience managing vendor interactions, including resolving technical and documentation-related challenges
• Background in capital projects (CapEx) with the ability to handle multiple priorities in a fast-paced setting

Core Responsibilities

• Develop and own end-to-end commissioning and qualification documentation, including protocols, reports, and supporting materials, from concept through final approval
• Create and manage change control documentation (CLIAs), ensuring compliance with site standards and regulatory requirements
• Partner with vendors and internal stakeholders to align on scope, timelines, and documentation deliverables
• Drive resolution of technical and documentation-related issues through effective communication and negotiation
• Support execution of large-scale projects by ensuring documentation readiness and accuracy throughout the project lifecycle