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 operations
Qualifications
* 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
* Experience working in a regulated manufacturing environment (e.g. pharmaceuticals, healthcare, food)
* Exposure to aseptic or sterile manufacturing
* Working knowledge of Lean / Six Sigma methodologies
Benefits
* Life assurance
* 32 days annual leave
* Company sick pay
* Employee wellbeing and assistance programmes
* On-site parking and canteen facilities
* Employee perks and discount schemes
* Recognition programmes and career development opportunities
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