The Senior Process Engineer will own and optimize manufacturing value streams for medical devices, ensuring safe, compliant, and cost‑effective production. The role provides strategic technical leadership, directs complex process development and validation programs, leads multi‑functional continuous improvement initiatives, and influences long‑term process and equipment strategy.
The Senior Process Engineer owns and optimizes assigned manufacturing value streams to ensure safe, compliant, and cost‑effective production of medical devices. In this role you will provide strategic technical leadership, direct complex process development and validation programs, lead multi‑functional continuous improvement initiatives, and influence long‑term process and equipment strategy. You will mentor junior engineers, represent Engineering in governance and regulatory forums, and drive initiatives that improve quality, supply continuity, and cost performance.
Required Qualifications & Experience
- Bachelor’s degree or equivalent experience in Engineering (or equivalent).
- Demonstrated ability in manufacturing/process engineering.
- Demonstrated experience leading validation activities including IQ, OQ and PQ for equipment, processes and systems.
- Proven track record managing Audit Actions, NCRs and CAPAs within a Quality Management System.
- Strong experience in structured problem solving and root cause analysis.
- Excellent technical content skills (specifications, validation protocols, change control).
- Experience leading multi‑functional teams and influencing collaborators at multiple levels.
Key Competencies
- Strategic and analytical problem solver with data‑driven decision‑making skills.
- Structured problem solver with a focus on root cause and sustainable corrective actions.
- Strong multi‑functional collaborator and influencer (Operations, Quality, R&D, Suppliers); able to represent Operations in governance and regulatory settings.
- Excellent written and verbal communication skills for technical content and collaborator updates.
- Project organisation, prioritisation and execution with the ability to drive complex actions to timely closure.
- Continuous improvement attitude with measurable focus on cost, quality and supply stability.
- Commitment to Health, Safety and Environmental (HSE) practices and regulatory compliance.
Required Skills
- Continuous Improvement, Process Validation, Quality Validation
Preferred Skills
- Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing
Location: Onsite, Blackpool, Lancashire, United Kingdom.
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