Engineering Associate Director; AD - Device Assembly

Role Summary

Engineering Associate Director (AD) - Device Assembly leads the staffing, training, and leadership of the engineering group (process, automation and maintenance) supporting asset delivery, process development, commissioning, qualification, validation and startup of the packaging lines for the site expansion project. After startup, the Engineering AD supports day-to-day engineering activities and planning for the 3–6 month horizon. The role requires leading by example and coaching others in safety, quality, engineering, optimization and continuous improvement.

• Manage Engineering and Maintenance support for Commercial Manufacturing Operations
• Manage team of process and automation engineers and maintenance technicians providing Front Line support in one or more areas:
  Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection), Device Assembly, Packaging Operations, Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.), Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (i.e., Refrigerators, Incubators, Cold Rooms, etc.)
• Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area
• Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives
• Understand, ensure and decision making based on engineering standards and policies, procedures and business plan that impact the ability of the team members to meet performance objectives
• Provide Functional Leadership to engineering and maintenance representatives by coaching the following business processes:
  Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
• Lead, support and peer review root cause analysis around equipment and operational events, support complex change controls and quality investigations with strong Root Cause analysis focus
• Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization
• Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvements
• Support regulatory inspections
• Utilize control systems to monitor, trend and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, yield performance, loop tuning, recipes, etc.
• Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem-solving techniques are appropriately utilized. On call/off hours support required
• Understand and ensure compliance with environment health & safety requirements
• Present and attend various Governance teams to represent engineering
• Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation
• Support commissioning and qualification activities

• This position involves direct management of front-line & SME engineering and maintenance team members
• Provide leadership, training, development, coaching and support of engineering team members
• Engage and promote use of internal and external networks and partnerships to help deliver sound technical decisions
• Promote use of first principles with engineering staff and drive engineering solutions for problems
• Monitor and ensure compliance with quality requirements. (trainings, CAPA, deviations)

• Required: At least 7 years process engineering experience

• Bachelor's degree in engineering

• Leadership and people management of front-line and SME engineering/maintenance teams
• Coaching, development, and mentoring of engineering staff
• Strong technical aptitude and ability to train and mentor others
• Experience with highly automated equipment and manufacturing execution systems
• Knowledge of regulatory requirements (FDA, EMEA, DEKRA, OSHA) and quality systems
• Experience with device assembly, parenteral operations, packaging, aseptic processing
• Root cause analysis, deviations/investigations, CAPA and change management
• Data analysis and statistical thinking for process variability and optimization
• Experience with commissioning and qualification activities and capital projects
• Effective collaboration with governance bodies and cross-functional teams

• Up to 20% travel (and more during startup)
• On-call as applicable
• Shift work may apply