Deviation Management Engineer

About the Role

We are looking for an experienced Deviation Management Engineer to support our client, a leading global pharmaceutical company, in managing a surge in site deviations. The successful candidate will be embedded within the Quality team and play a critical role in ensuring all deviations are investigated and closed within the required 30-day regulatory timeline.

Key Responsibilities

• Lead end-to-end deviation investigations, including root cause analysis and impact assessment
• Manage and prioritise a backlog of open deviations to meet closure deadlines
• Liaise with cross-functional stakeholders across Manufacturing, QA, QC, and Engineering to drive timely investigation and sign-off
• Develop, assign, and implement Corrective and Preventive Actions (CAPAs) arising from investigations
• Author high-quality deviation reports and investigation summaries in line with GMP documentation standards
• Ensure all records are audit-ready and compliant with regulatory requirements

Requirements

• Degree in Chemical Engineering, Pharmacy, Biological Sciences, or a related discipline
• 4 years of experience in deviation management, QA, or process engineering within a GMP-regulated environment (senior profiles welcome)
• Strong GMP documentation and deviation writing skills
• Experienced in root cause analysis methodologies (e.g. 5-Why, Fishbone)
• Solid understanding of CAPA processes and quality systems
• Effective communicator with strong stakeholder management skills