Process Capability Technician

Description Overview

As a Process Capability Technician, you will play a key role in driving quality and efficiency improvements across our pharmaceutical manufacturing processes, with a focus on tablet, capsule, and sachet product formats. 

You will support the introduction of new products, raw materials, process changes, and equipment modifications, ensuring compliance with cGMP standards and contributing to operational excellence.

Scope of the Role

Process Improvement & Quality Focus

• Lead and support projects aimed at enhancing manufacturing capability and product quality.
• Collaborate with cross-functional teams to implement changes to products, equipment, and processes.
• Apply Lean and Six Sigma principles to identify and eliminate inefficiencies.

GMP Compliance & Data Integrity

• Ensure all activities are conducted in compliance with cGMP and regulatory requirements.
• Create and maintain batch manufacturing records to ensure compliance with cGMP, product licenses and in process specifications.
• Support investigations into non-conformances and out-of-specification results, identifying root causes and implementing corrective actions within production processes.

Planning & Scheduling

• Take the lead role in optimisation exercises that aim to drive efficiency, health and safety or quality initiatives working closely with Planning, Manufacturing, Laboratory and Production teams.

Cross-Functional Collaboration

• Regularly communicate and work alongside manufacturing, production, planning, validation, engineering and other departments to ensure smooth operations.
• Proactively identify and resolve issues that may impact other functions.
• Promote a culture of continuous improvement and employee engagement.

Experience Required

• Minimum GCSE Grade C (or equivalent) in English Language, Maths, and Science.
• Experience in a pharmaceutical or regulated manufacturing environment.
• Ideally, a BSc or equivalent in a relevant scientific discipline (e.g., Chemistry, Pharmaceutical Science) with evidence of statistical analysis.
• Strong working knowledge of cGMP
• Proficiency in Microsoft Office (Word, Excel).
• Lean Sigma training or demonstratable experience in process improvement initiatives.
• Technical writing skills, ability to coherently and concisely write technical protocols and reports
• Ability to use Minitab preferred but not essential. Awareness of SAP systems useful but not essential.