Senior Process Engineer
Overview
An established global manufacturing organisation is seeking a Senior Process Engineer to join its Manufacturing, Science and Technology (MS&T) function. This role plays a key part in ensuring product quality, process reliability, and continuous improvement across commercial manufacturing operations, while supporting the transfer and scale-up of new products from R&D.
The successful candidate will work cross-functionally to investigate and resolve manufacturing issues, analyse process data, drive efficiency improvements, and ensure compliance within a regulated GMP environment.
Key Responsibilities
Lead Out of Specification (OOS) investigations, identifying root cause and implementing robust CAPAs to prevent recurrence
Author and review technical documentation including investigation protocols and reports
Identify sources of process variation and support corrective and preventative actions
Monitor critical process parameters and quality attributes for commercial products
Develop and maintain SPC systems and Out of Control Action Plans (OCAPs)
Provide day-to-day technical support to manufacturing operations and troubleshoot production issues
Drive continuous improvement initiatives using Lean and Six Sigma methodologies
Lead and manage change controls, assessing impact and communicating with Operations and Quality teams
Review production and batch documentation to ensure alignment with manufacturing processes
Collaborate with cross-functional teams including Operations, Quality, Engineering, Validation, and R&D
Support GMP compliance, audits, and process safety/risk assessments
Assist with training and mentoring of junior team members
Provide occasional out-of-hours support where required by continuous operation
Essential Criteria
Degree qualified (or equivalent) in Chemical Engineering, Process Engineering, Product Engineering, Chemistry, or a related discipline
Minimum 6 years’ experience in a process engineering or technical role within a manufacturing environment
Demonstrated success in technical process improvement initiatives
Strong problem-solving skills with proven expertise in root cause analysis
High proficiency in statistical analysis to identify trends and process variability
Desirable Experience
Experience working in a regulated manufacturing environment (e.g. pharmaceuticals, healthcare, food)
Exposure to aseptic or sterile manufacturing