Core Responsibilities
1. Process Innovation & Capital Projects
- Technology Roadmap: Identify and champion the integration of automation and robotics to drive plant efficiency.
- Lifecycle Management: Lead the end-to-end process for new equipment-from URS and vendor selection to Capex approval and FATs.
- R&D Partnership: Collaborate with Product Development to establish equipment requirements for new product introductions (NPI).
2. Equipment Validation & Transfer
- Validation Leadership: Execute seamless equipment validation and cross-site transfers in compliance with E&AS and GMP requirements.
- Operational Excellence: Lead VIP (Value Improvement) and STAR (Strategic Activity) projects to optimize manufacturing output and ROI.
3. Technical Support & Maintenance
- High-Level Troubleshooting: Act as the technical lead for debugging complex automated systems and production issues.
- Asset Care: Develop and implement rigorous maintenance and calibration protocols to ensure processes remain in control.
- Leadership: Manage departmental resourcing, hiring, and the technical upskilling of the engineering team.
4. Quality & Compliance
- Regulatory Alignment: Ensure all documentation and processes meet Quality System regulations and global safety standards.
- Continuous Improvement: Foster a culture of Lean manufacturing and maintain strong technical ties with sister sites.
Qualification Requirements
- Education: A Level 8 Honours Degree in Mechanical, Manufacturing, Electrical, or Biomedical Engineering (or a closely related technical discipline).
- Experience: 5+ years of experience in a high-volume regulated manufacturing environment (e.g., MedTech, Pharma, or Electronics).
- Technical Mastery: Deep expertise in Validation (IQ/OQ/PQ) and automated systems (Robotics, PLC, Vision Systems).
- Project Management: Proven track record of managing large-scale Capital Projects and departmental budgets.
