EDUCATION REQUIREMENTS

• Bachelor’s degree in Mechanical Engineering or closely related scientific field

EXPERIENCE

• 5+ years working within a pharmaceutical manufacturing or medical device environment
• 3-5 years of leadership experience, directly supervising a team of engineers, technicians, or contractors

• Manage equipment and utility related projects, including: on-site installation, startup, and commissioning activities for new equipment/systems
• Ownership of process equipment including continuous improvement and reliability activities, modernization/upgrades, event investigations/root cause analysis, cost reduction, and performance trending
• Primary/First Line responsibility for developing new processes and equipment to support business initiatives.
• Assist in the development of a robust operations and maintenance strategy
• Assist in the development of reliable and cost-effective spare parts program.
• Generate user requirements and engineering specifications for new equipment within area of responsibility
• Supports Operations including troubleshooting, emergency response, and normal coverage of a 24/7 manufacturing operation.
• Coordinate and conduct risk assessments
• Reduces downtime in accordance with applicable company and regulatory guidelines
• Responsible for the reliability of the production process (reliability of Validated Systems, Critical Utilities, and Production related systems is critical to the ability of the Lexington Facilities to successfully manufacture parenteral products).
• Improves key metrics (KPIs) around planning and scheduling (unplanned downtime, OEE, etc).
• Develops/reviews and approves design documents, drawings, project plans, change controls, SOPs, PMs, cals, work orders, validation protocols and final reports and ensures compliance with cGMPs and current regulatory requirements. Resolves all deviations/discrepancies encountered during project execution.
• Reviews change requests for impact to equipment or process and supports QA compliance activities such as Product Quality Review.
• Represents Technical Subject Matter Expert (SME) in equipment, facilities, process and utilities.
• Offers input for all functional budgeting, hiring, mentoring, employee evaluations and future direction of the Facilities/Engineering functions
• Provide support with customer requirements, communications and resolution of issues.
• Drive the manufacturing equipment/technology, automation, and facility strategies forward.
• Drive process improvement and lean manufacturing thru the corkscrew model of define, measure, analyze, improve and control to gain tangible improvement year over year.
• Lead process and product scale-up throughout the site, including troubleshooting complex engineering problems
• Ensure successful technological transfer of new products developed from R&D to commercial manufacturing and commercial site transfers.
• Manage / update site master plan to ensure alignment with strategy and updates to business and outside landscapes.
• Manage the Engineering Budget by monthly review and cost controls to ensure compliance
• Audit cGMP documentation of work performed.
• Ensure pFMEA is followed and that the process output for required spare parts inventories is maintained
• Provide performance management including career development, coaching & mentoring, and adhering to the PPS timelines and milestones for performance reviews and goal setting for all direct reports.