Brian Maschino Email & Phone Number

Bloomington, In, Us

Indiana, United States

Providing engineering and organizational consulting, contracting, and solutions in the pharmaceutical industry.

Bloomington, Indiana, United States

Catalent is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. The Bloomington site is one of Catalent's main biologics manufacturing facilities, and is responsible for providing a range of services including process development, clinical and commercial manufacturing, and analytical development for biologics. The site is approximately 60 acres with 1 million square feet of administrative, laboratory, production, packaging, R&D, and warehouse space.Led and managed a team of 8 direct reports and 310 total reports across capital project management, hard services, soft services, automation, process engineering, and facility/utility engineering. Delivered capital projects on time and on-budget while ensuring that operations were maintained at highest level of safety, quality, and compliance based on industry expectations, statutory requirements, and ISO/PDA/ISPE guidelines.• Successfully managed site capital plan, ranging from $60M to $160M per annum, ensuring timely and efficient execution of all capital projects.• Re-organized department and reduced headcount by 30% by reducing inefficiencies and overlap in roles.• Reduced departmental OPEX budget by $6M, 10% (excluding employee costs) for department expense budget of $60M, providing financial leadership and stewardship to optimize spending while meeting operational needs.• Developed and implemented strategic plan for engineering operations department, aligning with site's overall goals and objectives.• Implemented continuous improvement culture, leading to increased efficiency and effectiveness across all functions under engineering operations umbrella.• Sponsored and co-led site OEE improvement project bringing two key lines from 6% and 16% to 16% and 21%, respectively, in less than six months.

Zebulon, North Carolina, United States

GSK is a global healthcare company that develops, manufactures, and markets generic and branded prescription and consumer products. The Zebulon site specializes on respiratory inhaler technologies/devices, along with oral solid dosage, and packaging operations. The site is approximately 220 acres, housing 1.2 million square feet of administrative, laboratory, production, packaging, R&D, and warehouse space.Led site engineering department with five direct reports and 107 total personnel (37 FTE, 70 contingent workers) which included capital project management, hard and soft site services, operations engineering, automation, and facility design / engineering compliance. Created and oversaw engineering department operational budget ($40M). Developed, tracked, reported, and owned site capital ($39M in 2022) budget, ensuring accurate cash forecasting, along with quick response to business needs. Incorporated GSK’s continuous improvement philosophy (GPS) and project management framework (PMF) into all levels of group. Provided engineering organization that was sustainable, with robust published development and succession planning for all levels in group to ensure fault tolerance, promotability, resilience, and security of supply.• Re-organized department to let employees succeed in their style of work, along with reducing department operating budget by $2M, increasing capital project adherence to plan (7% increased accuracy YOY), and favorable impact to COGS ($0.10/unit).• Sponsored and led partnership with local high school, creating academy in school that better equipped, prepared, and trained high school students to directly enter apprenticeship after graduation.• Led EQ and leader lab sessions, improving employee psychological safety (incremental step to high performing team).• Sustainability improvements - site reduced carbon emissions (real and effective) by 3%, reduced waste by 5%.

Decatur, Illinois Area

Akorn was a niche pharmaceutical company that developed, manufactured, and marketed generic and branded prescription pharmaceuticals as well as animal and consumer health products. Akorn in Decatur specialized in difficult-to-manufacture sterile dosage forms including ophthalmic and injectables, along with secondary packaging.Served as functional head of engineering department with six direct reports and 73 total personnel which included security, engineering, project management, facility and process maintenance, automation, and calibration. Created and maintained engineering department budgets ($7M). Developed, tracked, and reported site capital ($9 to $25M) budget, ensuring accurate cash forecasting, along with quick response to business needs. Maintained all equipment, facilities, and departmental personnel in state of readiness to maximize up-time and efficiency.• Re-organized department to better position for sustaining high growth mode while not sacrificing safety, quality, or reliability.• Updated site facility specifications, procedures, and long-term plans to reflect ISO/EU standards, replacing Fed 209E legacy standards.• Implemented technical development professional rotational and development program for graduate engineers (four per year) to onboard and fast-track internal talent.• Implemented career lattice system for maintenance, operations, and calibration associates to cross-train and develop at their own pace and per their own affinities, with targeted incentives based on business benefits and needs.• Upgraded, retrofit, and/or requalified equipment – Serail Lyophilizers.• Led effort to successfully re-launch Mycophenolate, first to support commercialization in industry other than innovator. • Oversaw and engineered capital projects for installing Fedegari autoclave and RABS.

Vandalia, Oh

Carried out leadership role and was functional head of engineering department with nine direct reports and 25 total personnel which included EH&S / PSM (process safety management), security, engineering, capital project management, facility and equipment maintenance, and calibrations. Created and maintained engineering department budgets ($4M). Developed, tracked, and reported site capital ($5M) and global capital ($11M) budgets – ensuring accurate cash forecasting, along with quick response to business needs. Communicated across organization at various levels effectively. Maintained all equipment, facilities, and departmental personnel in state of readiness to maximize up-time and efficiency.• Implemented new change control systems that met 100% adherence - reducing complexity, ensuring due diligence on change owner, improving quality metrics, and reducing workload of validation department for minor changes.• Developed engineering document control systems from null to reflect as-built conditions and contain all engineering, safety, security, and quality pertinent data, ensuring new projects had solid foundation, increasing diligence, and making engineering decisions more defined/less contingency.• Implemented revised preventive maintenance, ensuring current and future equipment and facility reliability/availability, along with optimizing cost of program.• Developed long term strategies (5 and 10-year plans) to optimize facility and equipment utilization, integrated with capital plan - eliminating redundant or unnecessary spending while performing capital planning based on business priority.• Developed employees based on individual affinities, business needs, and succession planning, reducing turnover, increasing employee satisfaction, and creating contingency plans for critical position vacancies.• Implemented employee recognition system for site, rewarding employees for actions and behaviors that exceed expectations.

Seymour, In

Managed facility and equipment validation department with six full time direct reports plus two co-op engineers. Developed departmental budget as delegated by director of engineering ($5.9M). Maintained, monitored, upgraded, and designed expansions as needed for all site facility related functions – central utilities, building structure, security, camera system, card access, fire alarm, HVAC, and building automation. Specified and managed service contracts with all facility vendors, increasing equipment availability and performance, and ensured in-house personnel were performing routine functions while outsourcing specialized, high liability, and non-recurring functions.• Designed and implemented chilled water vari-prime system increasing both performance and efficiency resulting in capital avoidance of purchasing one chiller (400 tons, $600k) and 30% reduction in chiller electrical usage over 12 months.• Implemented a new design standard for contract customers – risk-based basis of design with conceptual design options and engineering estimates in a two-day workshop with a client, resulting in new construction and award of the manufacturing contract.• Performed basis of design analysis, conceptual design options, and estimates resulting in new construction and contract manufacturing while they were on site, in two days.• Headed design and qualification effort for two new production suites and multiple pieces of equipment, including two fluid bed dryers, 12 months from concept to production.• Represented engineering in audits from vendors, internal QA, parent company, and FDA as SME: no 483’s and no major observations resulted from facility, equipment, or engineering systems.

Seymour, In

Designed expansions and renovations including equipment integrations, building systems and equipment. Oversaw design and support tasks and projects associated with recommissioning, renovations, and expansions. Supported equipment systems and engineering systems. Conducted cross functional/departmental troubleshooting and recommended enhancements to prevent repeat failures. Upgraded and maintained Siemens building automation system (BAS) to achieve 100% uptime, meet data integrity requirements, and facility user training.

Seymour, In

Maintained and designed all facility-associated systems - HVAC, chiller, boiler systems, security systems, and automation systems. Supported maintenance and calibration groups. Designed, coordinated, and implemented HVAC system air rebalancing with setbacks in live environment for cost savings (less than three-month payback, over $300k saved/year), capital cost avoidance for utility systems ($1.5M), and increased pressurization reliability (maintained 15 Pa +/- 5 Pa continuously).

Seymour, In

Corrected and maintained facility-drawing system. Designed, built, and supported Siemens and Voltec Automation Systems. Designed, built, and supported facility card access systems. Organized, corrected, and catalogued all facility drawings in AutoCAD and created a drawing control system ensuring that there was only one accurate copy of each drawing.