Manages a team of engineers and technicians charged with maintenance, optimization, and upgrade of existing manufacturing equipment to achieve plant’s manufacturing goals. Participates in the purchase and install, start-up and validation of new equipment and/or processes as required to meet product specifications, requirements and manufacturing expectations.
Responsible for scheduled and un-scheduled maintenance for existing and new manufacturing equipment and processes in a manufacturing plant.
Design modification and improvement of production machinery and equipment to improve safety, quality and cost. Troubleshoot and solve technical problems pertaining to production machinery, equipment and processes.
Responsible for Preventive Maintenance compliance, effectiveness and budget. Responsible for Spare Parts availability and budget.
Provides assistance in all phases of Budget and Standards preparation (Labor, Spare Parts, etc.)
Designs, recommends and implements cost reduction projects within the scope of annual plant targeted goals.
Assesses resource skill requirements, labor loading, prioritization of work and time allocation for sustaining engineering activities and projects within a manufacturing plant.
Drives robustness evaluation and process/equipment improvements for new manufacturing and technology processes.
Establishes and drives effective project engineering management practices to plan and execute projects. Coaches team members in successful integration of structured development processes, engineering and risk management methods to insure a project's technical and business success. Maintains active involvement in all major projects for the manufacturing plant. Capable of taking on and completing sustaining engineering projects as well as overseeing the work of team.
Must be familiar with GMP's, ISO requirements, the IVD Directive, the CE Mark, Six Sigma and LEAN principles. Should have a working knowledge for validation of manufacturing processes within the IVD or pharmaceutical industries. Using validation methodology, works with QMRC to plan and validate process and equipment changes or start-up.