Summary
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Frank Reyes

Orlando,FL

Summary

Engineering Manager / Director with extensive expertise in the pharmaceutical industry, specializing in qualification, calibration, utilities, facilities, and building management. Recognized as an expert in process platforms, credited with establishing performance improvements that reduce costs, increase efficiencies, and enhance safety. Comprehensive leadership experience in driving impactful results within the pharma industry.

Work History

Head of Facility

SHL Medical
02.2023 - Current
  • Head of Facility directs design, planning, construction, implementation, calibration and maintenance of SHL’s US facility; responsible for developing budgets and long-range facilities plans based on company growth and future needs. This is a senior leadership role in our new facility in the US, reporting directly to site head.
  • Main Responsibilities:
  • Lead design, planning, construction, and maintenance of SHL facility and property
  • Develop budgets and long-range facilities plans based on company growth and future needs
  • Monitor facility budgets and approve contracts
  • Oversee all contractors involved in facility projects and delivery of services
  • Ensure building operations comply with all local zoning laws and regulations
  • Ensure functioning and availability of all building systems including mechanical, electrical, fire/life safety, plumbing, and waste management
  • Oversee day-to-day activities of the facilities maintenance group, including assignment and schedule management as well as coordination across the various site functional areas (utilities, process equipment, general site maintenance, etc.).
  • Ensure efficient, reliable, and safe operation of all equipment and utility systems
  • Development of the facility team in-line with company growth objectives and requirements

Director of Maintenance

PLASTIKON HEALTHCARE, LLC
10.2022 - 02.2023
  • Director of Maintenance responsible to direct, train and monitor technicians in preventative and corrective maintenance and repair activities to ensure the company’s machinery, systems, and equipment operate reliably and efficiently.
  • Oversees maintenance of injection molding, blow-fill-seal molding, and packaging equipment.
  • Oversees activities of facilities, maintenance and mold-maintenance department. Collaborates with Production Manager to schedule preventative maintenance and calibration activities.
  • Collaborates with the Plant Manager to build world-class Total Productive Maintenance teams that will keep production equipment in excellent condition, keep lines running at high efficiencies and maintain proper stock of all service and repair parts. Plans budgets and tasks accordingly
  • Oversees staff to coordinate outside contractors performing facility upgrades, construction projects, installations, repairs and projects at the facility
  • Develops, recommends, and implements measures to improve production methods, equipment performance, and quality of product
  • Analyzes and resolves work problems or assists workers in solving work problems.
  • Maintains time and maintenance records
  • Develops capital equipment justifications for machine tools and process technology to improve quality, cost and cycle times
  • Assists and oversees department budget

Sr. Manager, Facilities Engineering

Aveva Drug Delivery Systems
04.2022 - 10.2022
  • Develop and manage comprehensive budgets for engineering, maintenance, calibration and technical operations, aligning with organizational goals and financial guidelines. Monitor expenditures, analyze cost drivers, and identify opportunities to optimize spending and improve cost efficiency.

Senior Manager, Maintenance / Utilities

ADMA Biologics
11.2021 - 04.2022
  • Direct the work of the maintenance department of a pharmaceutical manufacturing operation comprised of managers, supervisors, and mechanics. Include but are not limited to plant utilities generation and distribution, machine tools, buildings, grounds, HVAC, Chillers, Cooling Towers, electric, gas, water for injection, boilers, Chillers -34F, -20F, -10, -5F for Freezers and air systems, sewer and waste disposal systems, and fire protection systems.
  • Manage critical low temperature cooling generation and distribution. Responsible for 25C Cooling water, 7C Chilled Water, -10C and -20C Propylene Glycol, -34C paratherm. Additionally, Boilers for plant steam, BMS, HVAC, Electrical, etc.
  • TPM, Lean, Continuous Improvement Work Environment. Lead / participate in cross functional teams to address process improvement initiatives.
  • Plan, layout, and schedule work for functional areas of responsibility and delegate work on a project or individual basis to departmental team members.
  • Hire, train, monitor, mentor, discipline, evaluate and develop team members. Assist troubleshooting, diagnosing, and remedying difficult personnel matters. Enforce organizational policies and employee rules of conduct.
  • Monitor and regulate the operation of departmental areas and investigate solutions to complex problems affecting functional areas of responsibility.
  • Source and manage outside vendors and service providers including but not limited to maintenance contracts, grounds keeping, facility and/or system inspection and certifications, etc.
  • Develop and implement a comprehensive preventative and predictive equipment repair programs including formal control programs to track and regulate repair costs and spare parts inventories for site.
  • Partner with internal and external resources to design, plan, schedule and complete capital improvement projects. Manage assigned projects from development, estimating, procurement, execution, and closeout while ensuring all regulatory and ADMA requirements are met.

Associate Director, Site Engineering

TEVA PHARMACEUTICAL (formerly ACTAVIS / ALLERGAN)
01.2016 - 01.2021
  • Under general direction, responsible for directing and controlling all aspects of packaging engineering activities including validation, Maintenance, Facilities & Utilities of a 320K sqft building. Ensures that all operating phases of packaging, maintenance, facilities, utilities, and engineering are performed in a safe and secure manner and are in total compliance with established cGMP and corporate/site SOPs.
  • Oversees the review, selection or design of packaging line equipment, facilities & utilities which will optimize efficiency while ensuring compliance with cGMPs and FDA regulations.
  • Oversees the coordination of technical reviews, selections, installations and maintenance of advanced electronic/optical verification systems.
  • Oversees the implementation of packaging conversions designed to achieve full optimization through the use of existing and new resources; ensures compliance with cGMPs and FDA.
  • Oversees, monitors and coordinates Business, Product Development and Manufacturing activities to assure packaging development for new products, including change management, component functionality and new product planning and execution regarding all packaging products.
  • Advances packaging validation and qualification on equipment including facilities / utilities such as HVAC, Chillers, Boilers and performance to ensure equipment is validated according to current Good Manufacturing Practices and Food and Drug Administration (FDA) standards.
  • Oversees, participates and approves the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports; assists direct report managers with performance evaluation process for their units.
  • Develops, communicates and implements improved operating efficiencies including packaging cost containment and ancillary rationalization plans, which can entail those areas that affect the purchasing of packaging equipment and supplies as well as identifying other qualified vendor/suppliers that may result in cost savings as well as improving customer service levels.

Associate Director, Engineering Operations

ALLERGAN PHARMACEUTICAL (formerly ACTAVIS)
01.2005 - 01.2015
  • Responsible for facilities, maintenance, engineering, equipment qualification, site security, computer validation, calibration, and promotion of corporate environmental health and safety functions in a multi building campus, (8 Bldg.). Manage a team of 60 -70 staff, including performance reviews and improvement plans. Oversee an annual budget of $9M and capital budget of $17M. Apply total quality management tools and approaches to production, analytical and reporting processes.
  • Guide and coach managers / supervisors in meeting corporate business plans and objectives.
  • Provide manufacturing, packaging, facilities & utilities support to problem-solving activities in order to comply with quality compliances, such as CAPA, deviations, change control, risk analysis, root cause analysis, supplier issues, etc.
  • Drive development and implementation of site facility / utility planning process, while supporting internal customer needs.
  • Represent the manufacturing, packaging, Facilities / Utilities and Engineering during FDA audits.
  • Provide facility / utility planning support to Company internal customers.
  • As special assignment, provide support to Allergan, Fort Lauderdale facilities for direct packaging engineering manufacturing areas.

Education

Bachelor of Science - Mechanical Engineering

University of Puerto Rico
Mayaguez, PR

Skills

  • Engineering Department Leadership
  • Program Management
  • Performance/Efficiency Improvements
  • Budgeting/Cost Reduction
  • Resource Management
  • Team Leadership
  • Metrics and Measurement
  • Collaboration
  • Service Delivery
  • Communication
  • Staff Recruitment and Training
  • Opportunity Identification
  • Subcontractor Management
  • New Product Packaging Design
  • Development Experience in a diverse range of facilities / utilities equipment, maintenance, engineering, equipment qualification, site security, computer validation, calibration, safety functions in a multi building campus, (8 Bldg) in the healthcare industry:
  • Extrusion
  • High Speed assembly
  • Liquid Filling (aseptic and non-aseptic)
  • Formulation
  • Automation
  • Tablet Press
  • Capsule Filling
  • Autoclave
  • Lyophilisation (Freeze drying)
  • Syringes aseptically filled
  • Packaging
  • Serialization
  • USP Standards for Packaged Purified Water (Reverse Osmosis Membrane Technology / DI mixed beds resin cartridges)
  • Chilled water system
  • Cooling Towers
  • HVAC
  • Boilers & Steam Distribution

Certification

  • EIT License
  • Lean Six Sigma Green Belt, Six Sigma US
  • Analytical Troubleshooting Program Leader, Kepner-Tregoe
  • Project Management, Watson Pharma
  • PLC Programming, JR Electronics & Pneumatics Corp.
  • Air & Water Balancing Seminar, Mechanical Seals Seminar, Maintenance Engineering

Languages

Spanish
Native or Bilingual
English
Full Professional

Timeline

Head of Facility

SHL Medical
02.2023 - Current

Director of Maintenance

PLASTIKON HEALTHCARE, LLC
10.2022 - 02.2023

Sr. Manager, Facilities Engineering

Aveva Drug Delivery Systems
04.2022 - 10.2022

Senior Manager, Maintenance / Utilities

ADMA Biologics
11.2021 - 04.2022

Associate Director, Site Engineering

TEVA PHARMACEUTICAL (formerly ACTAVIS / ALLERGAN)
01.2016 - 01.2021

Associate Director, Engineering Operations

ALLERGAN PHARMACEUTICAL (formerly ACTAVIS)
01.2005 - 01.2015

Bachelor of Science - Mechanical Engineering

University of Puerto Rico
Frank Reyes