- Develop new equipment/processes as necessary.
- Develop and implement the appropriate maintenance procedures and protocols to ensure processes always remain in control.
- Oversee the specification and purchase of capital equipment ensuring balance between optimizing technological capabilities and return on investment.
- Manage the planning and execution of equipment qualification as per the equipment introduction strategy requirements.
- Providing technical leadership on maintenance and equipment issues
- Collaborate with manufacturing function on OEE improvement programs.
- Provide effective and responsive Calibration support to Operations to meet their area’s objectives of quality, cost and output.
- Responsible for developing a world class-manufacturing group that is proficient in problem-solving manufacturing issues using Six-Sigma tools.
- Drives IBP (Integrated Business Plan) contract deliverables by providing input on process technology selection.
- Initiates cross-functional partnerships to identify and resolve production/engineering issues.
- Prioritizes and drives execution of multiple complex department projects. Sponsors and supports Operations Value Improvement Process (VIP) or Strategic Activity Review (STAR) projects.
- Responsible for the departmental basics including budgeting, hiring, day-to-day management, project resourcing, etc.
- Establishes and supports a work environment of continuous improvement that supports Quality policy, Quality System & the appropriate regulations for the area.
- Ensures employees are trained to do their work and their training is documented.
- Maintain compliance metrics around adherence to preventative maintenance schedule and calibration schedule.
- Ensure relevant documentation is prepared and updated in line with all Quality and Regulatory guidelines and promotes full compliance to all GMP & E&AS requirements.
- Keep abreast of all relevant technological advancements.
- Maintain and develop the team’s technical and trouble shooting skills.
- Sustain an environment of continuous improvement.
- Develop and maintain relationships with technical management in sister sites and R&D
- Bachelor level degree in Engineering or another relevant technical equivalent. Master qualification advantageous.
- 1-2 years’ experience in similar equipment related role in a GMP regulated environment
- Experience in Automation activities such as Debug
- Equipment qualification experience
For a confidential discussion and more information on the role, please contact Josh Barnes.