Senior Manufacturing Engineer

About the role

We are seeking a Senior Manufacturing Engineer to join an award‑winning pharmaceutical organization in Cork on a 12‑month contract. You will lead savings‑type projects, apply engineering and Lean problem‑solving techniques, and ensure manufacturing processes meet quality, safety and regulatory standards.

Key responsibilities

• Represent the End‑to‑End Engineering function on quality, savings, capacity and validation projects across the orthopaedic product range.
• Prepare project documentation covering scope, design, implementation and execution.
• Identify and drive savings related to direct labour inefficiencies, scrap and consumables spend.
• Align new or amended manufacturing processes with operational, quality, EHS, validation, finance, automation and maintenance requirements.
• Present weekly status updates and funding needs to senior management.
• Determine machine input/output ranges prior to validation and conduct IQ, OQ, PQ activities as required.
• Partner with Quality, Operations, CSV and other cross‑functional teams to apply design controls, risk management and resolve design failures.
• Communicate project status, issues and requirements to global functions and internal stakeholders.
• Ensure compliance with GMP, ISO, and all health, safety and environmental regulations.

Required profile

• MSc in Engineering or Science with at least 7 years of experience in medium‑to‑high volume manufacturing (e.g., food processing, paint, oil & gas, orthopaedics).
• Minimum 2 years in a regulated environment (FDA/ISO) with knowledge of 21 CFR 820, CFR 11 and European medical‑device regulations.
• Strong understanding of GMP, ISO and validation requirements.

Required skills

• Six Sigma / Black Belt methodology
• Lean Manufacturing techniques
• Project Management best practices
• Statistical analysis for process improvement
• GMP and ISO compliance
• Validation procedures (IQ, OQ, PQ)
• Regulatory knowledge (FDA, EU medical‑device regulations)