As the Director of Facilities at a fast-growing biotechnology and medical device start-up, I oversee all aspects of facilities, facilities engineering, maintenance, calibration, validation, and EHS, My responsibilities include developing and implementing strategic facilities plans to address future space constraints, operational challenges, and managing transitions to new locations.Collaborating closely with architecture and construction firms, I play a key role in lab and GMP manufacturing plant design, ensuring efficient planning and execution of capital investments in facility infrastructure and equipment. I lead the design, installation, maintenance, and operation of facilities systems and procedures, while overseeing GMP and non-GMP utilities, waste systems, and HVAC.In my position, I also build and manage equipment maintenance, metrology, security access, and pest control programs, directing and managing employees and contracted services as needed. I am fully responsible for the safe, clean, compliant, and efficient operation of GMP manufacturing facility systems, as well as managing comprehensive Environmental, Health & Safety programs and processes, including hazardous materials management.Supporting facility CAPEX and OPEX budgeting and resource prioritization, I develop project scopes, user requirements, and specifications, coordinating the development and implementation of key standard operating procedures and policies for GMP drug/device combination products. Additionally, I actively participate in company risk management processes and contribute to business continuity planning for plants, laboratories, and offices.

Manage site engineering department with a staff of engineers and specialists (peak of 25 FTEs and contractors). Identified and filled critical staffing needs as the site transitioned from owner-based manufacturer to CDMO.Identify and execute complex engineering projects in support of annual site maintenance shutdowns. Troubleshooting of critical equipment including blast freezer, HVAC, compressed air, WFI, purified water, and clean steam systems.Developed and implemented reliability and maintenance strategies to reduce the risk and impacts of equipment failure. Manage compliance team responsible for all F&E deviations, CAPAs, and CCRs. Owner of cross-department daily huddle (engineering, facilities, maintenance, validation, and metrology). System Owner for EMS, BMS, DCS, Data Historian, and PLC source code management computer systems (Honeywell, Siemens Desigo, Siemens Apogee, DeltaV, OSI PI and Rockwell Asset Centre). In two years, reduced computer system major compliance gaps from over 100 to zero.Engineering and automation SME for multiple consent decree, agency, and corporate audits. Recognized by senior quality management for preparation, coaching, and zero audit findings.Manage CAD function for 1,000 site GEP & GMP engineering drawings. Drove P&ID backlog from over 300 to zero.

Executed the engineering and computer system lifecycle for site projects. Led engineering lifecycle activities including user requirements, system classification, system risk assessment, design review, design qualification, commissioning & qualification, ETOPs, requalification, and decommissioning. Built an Engineering Change Management process.Designed and executed engineering study to evaluate the impact of a temporary AHU shutdown on a classified environment. Study provided the basis for cleanroom recovery due to planned and unplanned HVAC outages. Benefits included:-Reduced delays in the production schedule due to required area cleanings.-Reduction of time and resources necessary to assess product impact.-Reduction in cost and labor bottlenecks due to the elimination of necessary environmental monitoring.Engineering lead for installation and qualification of airlocks between CNC and Grade C space.Led a cross functional team to define critical and non-critical EMS alarms using a risk-based approach, resulting in the elimination nearly all nuisance alarms.Led commissioning activities of the installation of a new WFI loop. Overcame significant obstacles of a very aggressive timeline, use of equipment from other sites, and contamination risks tying into an existing WFI loop. Manage CAD function for 1000 site engineering drawings. Drove P&ID backlog from 300 to zero.

Developed and implemented corporate programs for global biotech manufacturing, laboratory, and large office buildings. Oversite of HSE compliance and performance for over 20 sites.Led energy and carbon programs, ISO 14001 & OHSAS 18001 management systems, HSE auditing, and green buildings. The energy and carbon reduction program saved $600,000 per year (average 1.1-year ROI) and was recognized by EPA with the Climate Leaders Award. Secured future revenue of $200,000 per year for combined heat and power plant from Massachusetts Alternative Energy Portfolio Standard. Drove adoption of green building practices. Managed 3 projects that achieved LEED certification (1 Platinum, 2 Gold). Lead environmental engineer for multiple large construction projects, including new 1.2 MW combined heat & power plant in MA, office building additions to existing manufacturing sites in MA and NJ, new genetics testing laboratory in FL, and a mixed use (manufacturing, laboratory, and office) facility in Beijing. Led all HSE permitting and green building certifications.

Performed air permitting for industrial clients with complex regulatory issues. Focus on BACT, Title V, NSPS, NESHAP, and state permitting. Industries included pulp & paper, aluminum, petrochemical, oil and gas, combined heat & power, education, and pharmaceuticals. Over half of projects were repeat work due to effective project execution.