Provide overall direction to the Engineering organization including Process, Capital, Maintenance, Metrology, Utilities and Facilities. Directs the engineering teams and activities for new product introduction, commercial and clinical manufacturing. The role is accountable for Maintenance Excellence Program (MEP) metrics and the Perfect Index, leads the Capital Plan and LRP. In addition, the role provides leadership and direction for all Medical Device performance related activities on site, delivering quality and compliance across site. The role directs a cross functional team to drive initiatives that enable and deliver the highest standards of Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business priorities.
- Accountable for all processes, policies, procedures and execution related to Process Engineering, Capital Planning and Projects, Maintenance, Metrology, Utilities and Facilities
- Effectively leads the multi-disciplinary team to develop resource plans for approved projects and make recommendations regarding use of internal and/or external resources for projects/facility planning, design and execution.
- Responsible for maintaining medical device production systems in an audit-ready state of compliance at all times over the lifecycle from initial validation through retirement.
- Directs GMP and non-GMP equipment, facility and utility projects to ensure adherence to AbbVie Standards and Specifications. Establishes and maintains appropriate relationships with internal (manufacturing, quality, engineering and other areas) and external partners to coordinate and execute project plans to meet project design, schedule, cost and quality requirements.
- Responsible for strategic planning and facility asset utilization that advances the site, continually looks for opportunities for process optimization, cost avoidance and reduction.
- Leads and oversees discipline specific engineering expertise to provide Medical Device benchmarking of process equipment and quality system best practices within AbbVie.
- Responsible for managing and leveraging common engineering systems including SAP, Maximo, Meridian, and achieving maintenance and metrology schedules and deliverables/
- Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations. Coach the associate directors, managers and supervisors in the organization and establish clear expectations with all employees regarding responsibilities, goals and behaviors.
- Acts as site Subject Matter Expert for medical device manufacturing on site across all functions including Manufacturing, Quality, Regulatory, and Engineering. Drives all aspects of manufacturing performance on site through analysis of data, engagement of Site colleagues and development/execution of action plans. Drives a culture of Speak-Up.
- Accountable for the site quality and compliance strategy, owns and advises the Site Lead Team on the medical device quality program, championing and owning any recommendations for improvement of the quality management system.
- Drives the implementation of Best Practices related to Medical Device Manufacturing.