Senior Project Engineer - Manufacturing & Automation

Lead manufacturing performance, automation projects, and quality compliance within a regulated medical device environment. Act as the senior technical lead responsible for introducing new equipment, improving manufacturing processes, ensuring regulatory compliance, and supporting cross functional business objectives.

Key Responsibilities

• Lead the introduction of automated manufacturing equipment and production lines, managing the full lifecycle from design and commissioning through validation and production ramp up.
• Deliver capital and process improvement projects safely, on time, and in compliance with quality and regulatory requirements.
• Monitor and improve manufacturing performance, including output, yield, cycle time, downtime, and overall equipment effectiveness.
• Apply structured problem solving and continuous improvement methodologies to resolve technical issues and optimise processes.
• Ensure compliance with GMP, FDA, ISO, and internal quality standards.
• Lead and support validation activities (IQ/OQ/PQ) and maintain associated risk management and quality documentation, including FMEA and critical quality attributes.
• Collaborate with Operations, Quality, Regulatory Affairs, R&D, suppliers, and external manufacturing partners.
• Serve as the primary technical interface between engineering, quality, and manufacturing teams.

Experience & Skills

• 5+ years' experience in manufacturing, process, automation, or project engineering.
• Experience delivering automation or capital equipment projects within a regulated industry such as medical devices or pharmaceuticals.
• Strong knowledge of manufacturing systems, automation technologies, vision systems, process validation, and statistical analysis.
• Proven ability to lead projects, solve complex technical problems, influence stakeholders, and deliver measurable business improvements.
• Excellent communication, leadership, and cross functional collaboration skills.