Directs all engineering, maintenance, utility and building operations, metrology, facility planning, and capital projects in a state-of-the-art biopharmaceutical manufacturing facility. The Director, Engineering is accountable for achieving business objectives that ensure the building and equipment are designed for safe use by company employees, work schedules are adhered to, costs are contained, and work is performed in a manner that is compliant with government regulations.
- Oversees all preventative, predictive, corrective and emergency maintenance work for the site. This includes trouble-shooting of manufacturing, and utility operations ensuring reliability of equipment and instrument calibration, efficient utilization of maintenance resources, adherence to uniform policy practices amongst the site maintenance groups and cGMP compliance. This also includes sourcing of maintenance materials and outside purchased maintenance and appropriate inventory levels of spare parts and materials.
- Ensures the delivery of reliable utilities, which include steam, electric, compressed air, water, tower water, chilled water, well water, etc. to the site customers in a cost effective manner in order to keep the plant running. Responsible for power co-generation facilities.
- Directs the activities of engineering, maintenance and utilities personnel, managing departmental operating and capital budgets, site capital budget planning and tracking.
- Oversees development of an integrated site, utilities, infrastructure, space allocation master plans and the implementation of strategic objectives compatible with those of the functional groups on the site.
- Oversees development of employees within the departments ensuring training and development opportunities are provided for each employee’s continued growth and increasing contributions to the site.
- Develops and implements capital plans, which includes defining scope with customers, design and detailed engineering, project cost estimation, submitting appropriate justification and funding requests, and adhering to cGMP, budget, schedule, safety, and quality commitments.
- Ensures continuous monitoring and responding to all HVAC, refrigeration, stability chamber, alarm conditions, and instituting corrective measures per specific SOP’s. Delivers lean utilities to classified and restricted manufacturing areas on a 24/7 schedule.
- Responsible for forecasting the operating and capital budgets for the coming years. Administers the process within the section so that individual department budgets are compatible within the overall guidelines. Responsible for submitting the final section consolidated budget for approval
- Annual operating budget for the section is approximately $15MM, capital spending for the customer groups served are approximately $15-25MM, maintain physical assets valued in excess of $200MM.
EDUCATION and/or EXPERIENCE
- BS or MS in Engineering. MBA a plus.
- Specific training in biotechnology/pharmaceutical engineering practices, guidelines, validation principles, management practices, cGMP utility maintenance and operations.
- 20+ years of experience in biopharmaceutical/pharmaceutical processing industry
- 10+ years of progressive management experience in engineering services organizations.
- Large capital project experience.
- Demonstrated experience making decisions around the prioritization and assignment of work flow within the engineering services group.
- Successful track record responding to utility and equipment failures in support of 24/7 production operations.
- Demonstrated experience leading in the development of options and decision making on site master planning issues.
- Demonstrated experience making decisions on human resources issues when made within the departments approved budgetary guidelines.