- Manage the facilities engineering function to perform, and coordinate third party engineering support and services associated with all aspects of construction, modification and operation of facilities at the ADD Dallas site. Take the lead role to ensure compliance to Abbott Engineering standards, applicable building codes, fire/life safety codes and facilities related quality system compliance. This includes the role of subject matter expert (SME)for Equipment Control, Environmental Monitoring, Sanitation, Controlled Temperature Units and Deionized Water Maintenance and Monitoring. Take ownership and guide the Facilities Engineering team on LRP capital planning, project management, execution of capital projects, site space planning, execution of work orders, business continuity planning including annual exercise, and utility management. Acts as technical expert and liaison with Validation for Facilities/Utilities/Equipment validation activities.
- Identify and lead process improvement and cost savings projects.
- Manage the data systems team to prepare and conduct site Management Review (EMR), Business Review (MBR) and Product Monitoring Review (PMR) to meet all regulatory deliverables. Work across business functions to define metrics and reports. Create and verify site quality and business metrics and distribute to end users. Maintain Quality Impact Score Tool and Erratic Rate IT applications (lead Validation and Administration) and assign ticket trending evaluation.
- Act as SME during audits for Data Systems procedures and processes including Management Review and Product Monitoring. Act as SME during audits for Facilities procedures and processes including Equipment Control, Environmental Monitoring and Sanitation, Controlled Temperature Units, and Deionized Water. Provide CAPA technical support and provide responses for all areas of responsibility including Facilities and Data Systems.
- Responsible for 5-7 direct reports. Provide input on hiring within the group. Set expectations and monitor staff performance; write and conduct performance appraisals for employees; recommend merit increases and promotions; coach team providing guidance, direction, training, and resources.
Supervisory/Management Responsibilities: 5-7 Exempt direct reports
- Position is a management position reporting to Dallas Site Shared Services Manager.
- Leads function and manages employees responsible for facility engineering, space planning, quality and business metrics, validated QIST tool, validated Erratic rates tool, facilities compliance, management review compliance, and product monitoring compliance.
- Interfaces with 3rd party providers for support of metric applications such as QIST and Erratic Rates as well as 3rd party providers for facilities services.
- Interfaces with all levels of site management when leading EMR, PMR, and MBR reviews.
Minimum Education: BS in an Engineering discipline or equivalent technical discipline
Minimum Experience / Training:
- Minimum of 8 years’ experience within an FDA regulated environment with experience in plant engineering, quality and exposure to data analytics.
- Must have knowledge of HVAC equipment, building codes, and project management
- Must be proficient in MS Excel, PowerPoint and Microstation CAD software tools with knowledge of MS power tools a preference
- SQL and other query logic preferred
- Ability to work collaboratively with all functional areas on site
- Effective communication skills across all levels of the organization
- Leadership presence – ability to host business reviews with senior management
- Knowledge of regulations and standards affecting IVD’s and Biologics.