Deviation Writer

Position Overview

We are seeking an experienced Deviation Writer to support Manufacturing Engineering and Quality Operations within a GMP-regulated pharmaceutical or biotechnology environment. This role will be responsible for authoring high-quality deviation investigations, performing root cause analysis, and collaborating with cross-functional teams to ensure timely and compliant resolution of quality events.

Key Responsibilities

• Author, review, and manage deviation investigations within a GMP-regulated environment.
• Collaborate with Manufacturing, Production Engineering, MS&T, Supply Chain, Quality, and other stakeholders to gather facts and technical information.
• Conduct and document root cause investigations using structured problem-solving methodologies.
• Develop robust corrective and preventive action (CAPA) plans based on investigation outcomes.
• Analyze manufacturing and quality data to support investigation conclusions.
• Simplify complex technical events into clear, concise, and audit-ready documentation.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or a related technical discipline.
• Minimum 3 years of experience in technical writing within a regulated GMP environment.
• Experience authoring deviation investigations in pharmaceutical, biopharmaceutical, or biotechnology manufacturing.
• Strong Knowledge Of Root Cause Analysis, CAPA Development, Deviation Management, and GMP Regulations.
• Familiarity with Electronic Quality Management Systems (eQMS).
• Strong Microsoft Word and Excel skills.
• Excellent communication, documentation, and cross-functional collaboration abilities.