- Manage the daily activities, including organisation and coordination of work schedules, preventive maintenance, training, bespoke projects, and parts procurement.
- Provide technical and logistical support in project team meetings as necessary to guarentee success of projects
- Manage the relationships with several departments and management levels to allow identification, design, and implementation of manufacturing and engineering projects
- Input for vendor selection activities for capital equipment.
- Create, Implement and manage systems to improve efficiency contributing to site Value in Product target to deliver Year on Year standard cost reduction
- Ensure that programs and solutions are in place for increasing equipment uptime.
- Be main Manufacturing contact to ensure continuous operation of manufacturing equipment to meet supply chain forecast requirements.
- Manage and take charge of the maintenance, calibration documentation, and compliance requirements with vendors to ensure they are in place and meet current ISO/FDA standards
- Investigate technical requirements and initiate/upgrade preventive maintenance and calibration process specifications.
- Ensure department is fully resourced and employees are trained to appropriate levels using current company training systems
- Develop and implement Engineering and metrology documentation and SOPs.
- Manages and controls departmental budget and provides guidance to ensure the financial goals are met as set by Executive Management.
- Prepares and keeps track of headcount, expense and capital budgets according to marketing forecasts.
- Fully accountable for developing department goals and objectives; ensures achievement of department milestones and/or KPIs.
- Coach, mentor and lead the team into a culture of accountability, engagement and continuous improvement. Leveraging LEAN initiatives and principles of engagement to drive and deliver results
KNOWLEDGE, SKILLS AND EXPERIENCE
- Proven Senior Management experience with strong leadership skills
- Established experience in a cGMP environment
- In depth knowledge and experience of manufacturing automated and semi-automated systems and best design practice
- Worked in a highly regulated environment
- Demonstrated ability to follow detailed directions in a manufacturing GMP environment
- Fully understands manufacturing systems, processes and equipment (documentation, compliance, Safety, change control, time and attendance, etc.).
- Working knowledge of GMPs and ISO 13485/FDA 820 regulations.
- BSC Eng Qualification or equivalent
- Lean manufacturing certification and experience strongly desired