Mark Hernandez

Mark Hernandez Email and Phone Number

Director, Facilities and Engineering at Theragent @ Theragent Inc
Mark Hernandez's Location
Los Angeles County, California, United States, United States
Mark Hernandez's Contact Details
About Mark Hernandez

Results-driven engineering leader with 15+ years of experience managing facilities, engineering, and maintenance operations in pharmaceutical and biotech industries. Proven expertise in designing GMP-compliant facilities, leading capital projects, and implementing cutting-edge systems for critical utilities, cleanrooms, and manufacturing equipment. Adept at building high-performing teams, optimizing processes, and ensuring regulatory compliance in fast-paced, high-stakes environments. Known for a hands-on approach to problem-solving, strategic budget management, and delivering operational excellence.

Mark Hernandez's Current Company Details
Theragent Inc

Theragent Inc

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Director, Facilities and Engineering at Theragent
Mark Hernandez Work Experience Details
  • Theragent Inc
    Director, Facilities And Engineering
    Theragent Inc Jan 2023 - Present
    Arcadia, California, United States
  • Instil Bio
    Associate Director Facilities
    Instil Bio Jan 2021 - Jan 2023
    Los Angeles, California, United States
    • Responsible for Commercial (Tarzana) and Clinical Labs (Thousand Oaks) Facility infrastructure development and GMP readiness.• Developed and supported GMP facility design of cleanroom environments (AES) and critical utilities (N+1 redundancy design) in support of Clinical to Commercial ramp-up.• Managed facility build-out from basis of design (BOD) to obtaining temporary and permanent city occupancy permit. • Develop facility infrastructure for environmental monitoring (EMS) and building management system (BMS - Siemens). And responsible for monitoring, response, and operational readiness.• Developed and manage facility pest control program.• Developed facility infrastructure for control access across US Sites – Siemens CCURE.• Developed and manage Maintenance System program which included, implementation of Global Computerized Maintenance Management System – Blue Mountain Quality Resource (US/UK).• Develop and manage GMP and Non-GMP cleaning programs.• Develop and manage facility user requirements (i.e temperature, differential pressure, RH, etc.)• Developed facility and maintenance organizations in support of facility operations for Clinical and Commercial Operations. This include identifying and hiring industry talent and expertise.• Develop, propose, and manage facility operational (OPEX) and capital (CAPEX) budget.• Responsible for 365 days, 24/7 facility maintenance and operations (US).• Subject Matter Expert (SME) for Critical Utilities (HVAC, Electrical, Mechanical, Plumbing, Specialty Gases).• Provided technical expertise for site engineering and project management.• Developed and manage Metrology/Calibration program.
  • Immunitybio
    Director Of Engineering
    Immunitybio Oct 2020 - Jan 2021
    El Segundo, California, United States
  • Immunitybio
    Associate Director Engineering
    Immunitybio Jun 2017 - Oct 2020
    Greater Los Angeles Area
    (Responsible for Engineering and Maintenance, Metrology, Process Automation, and EHS)• Head of site Engineering and Facilities Operations• Responsible for 365 days, 24/7 facility maintenance and operations.• Responsible for site engineering operations and technical support for Critical Utilities (i.e. Compressed Air, Specialty Gases, HVAC, Process Waste, etc.)• Subject Matter Expert for Critical Utilities (Compressed Air, WFI, Process Waste, HVAC, Clean and Plant Steam)• Manage and develop direct reports for Engineering, Maintenance, and Warehouse/Procurement staff.• Developed preventative maintenance program for utility and process equipment.• Developed and lead the metrology and calibration program for all critical utilities and process equipment.• Provide technical oversight to the Engineering team for complex problems that require ingenuity and creativity.• Provide project management expertise and leadership for strategic organization initiatives.• Responsible for process automation program integration for facility research and development labs and manufacturing site• Responsible and develop site GMP and Non-GMP cleaning programs.• Developed Environmental Health and Safety (EHS) program for facility site (i.e. Emergency Response Plan, Facility Access and Security, etc.)• Developed site Environmental Monitoring Program and Compliance (i.e. Hazardous/non-Hazardous Waste, Air Quality Monitoring)
  • Baxalta
    Engineering Manager
    Baxalta May 2013 - Apr 2017
    Greater Los Angeles Area
    • Lead the Critical Systems Group in development, support, and improvements of the Los Angeles Plant Critical Systems process which includes water (WFI/RO), compressed air and nitrogen, process alcohol, plant and clean steam generation and distribution systems. • Responsible for 365 days 24/7 operations, maintenance, and engineering of the Critical Systems department• Developed and sustained a comprehensive training program for boiler operators and critical systems technicians• Drove the development of an integrated planning schedule in order to optimize resources and minimize impact to manufacturing• Lead daily stand up staff meetings to discuss current utilities operational and manufacturing issues, safety incidents, quality impacts, utilities availability metrics, change control documentations, and accountability boards.• Manage, identify, hire, develop, and recognize a full staff of Boiler Operators, Maintenance Technicians, Planner, and Engineers. Develop, mentor and coach the Critical Systems group members.• Manage and administer reliability maintenance strategies and methods in Critical Systems in order to provide maximum availability and reliability.• Manage and report on key maintenance performance such as WFI/RO availability, redistilled and fresh alcohol tank levels, plant and clean steam uptime• Assure, create, review, approve and oversee documentation to maintain appropriate and required records supporting Critical System operations and maintenance functions• Responsible for preparing budget, overall spending in Critical Systems cost center and meeting forecasts• Participate in internal and external regulatory audits and ensure group is following Critical System procedures and related Divisional/Corporate documents
  • Baxter Bioscience
    Principal Engineer / Critical Systems Supervisor - Process Engineer
    Baxter Bioscience Dec 2011 - May 2013
    Los Angeles
    • Responsible for 365 days 24/7 operations of Critical Systems Utilities for the Los Angeles site which includes: -Reverse Osmosis (RO) and Water for Injection (WFI) generation/distribution-Alcohol storage, re-distillation, and distribution-Compressed Air generation/distribution-Nitrogen storage and distribution-Plant Steam (Boilers) and Clean Steam generation/distribution• Responsible for ensuring Critical System produces qualified WFI and RO water, alcohol, compressed air, and steam / clean steam for manufacturing use up to point-of-use (POU).• Subject Matter Expert in Critical Utilities and support design, planning, commissioning, and validation of new systems.• Manage Critical Systems cost center which include budgeting for preventative maintenance cost, utility usage, contract maintenance, manpower and overtime.• Develop strategic department yearly goals to align with plant manufacturing goals tracking utilities downtime/uptime.• Develop yearly water balance for the Los Angeles site for city submission. • Address and respond to daily Critical System’s quality excursions.• Manage and lead numerous derouge and passivation projects.• Responsible for the operation and maintenance of sub WFI and cWFI storage and distribution system in Albumin Processing and Fractionation Department.• Manage 5 boiler operators, 4 senior maintenance technicians, and a maintenance planner.• Responsible for the health of Critical System equipment through execution of preventative maintenance activities and corrective work orders.• Responsible for Critical System Utilities uptime by decreasing unforeseen equipment downtime through the use of predictive technologies and coordination with manufacturing.• Lead Critical Systems Shutdown activities with multi-cross departmental planning and coordination.• Troubleshoot process and equipment issues when needed.• Manage Key Performance Indicators (KPIs
  • Baxter International Inc.
    Senior Engineer – Reliability Engineer
    Baxter International Inc. Nov 2010 - Dec 2011
    Los Angeles
    • Award Recipient for 2011 AME – Maintenance VIP savings of $4.6M.• Duties include executing Reliability Engineering tasks, functions, and projects.• Engineering duties expand supporting the Critical Systems group with maintaining the Los Angeles Plant RO and WFI Distribution System, Alcohol Recovery and Distillation System (ARDS), and Steam System.• Responsible for both writing and executing documentation and final reports.• Provide technical support in development of SOP’s and training materials for the operation and maintenance of equipment and processes• Perform engineering projects• Problem solve and make design recommendations for material and process specifications• Utilize reliability engineering tools to solve problems such as RCA and FMEA• Perform Pareto Analysis for Critical System corrective maintenance work orders• Develop and update Bill of Materials for Critical Systems equipment• Create Preventative Maintenance documents by initiating redlines and submitting to QMD• Manage the Predictive Technology program which utilizes the use of Thermography, Vibration, Ultrasonic, and Oil Analysis• Respond to emergencies and help troubleshoot equipment / system problems
  • Baxter International Inc.
    Engineer Ii – Reliability Engineer
    Baxter International Inc. May 2008 - Nov 2010
    Los Angeles
    • Primary duties include reinforcing a reliability centered maintenance program with the use of the following reliability tool: Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA)• Analyze corrective maintenance work orders to look for equipment failure trend with the use of Pareto Analysis. Pareto Analysis is a tool used for PM optimization • Perform criticality assessment to categorize equipments and their priority levels• Create Preventative Maintenance standard operating procedures (SOPs) for equipments. Equipments include Fractionation Manufacturing areas, Facilities Support, and Critical Systems• Keeper of Preventative Maintenance SOPs by tracking, creating, and grouping PM numbers• Maintain Preventative Maintenance documents by initiating redline changes and processing through Quality Management Documentation (QMD).• Work closely with Change Control Department to determine Quality Testing Requirements for new PMs.• Manage Equipment Hierarchy and equipment numbers for new and existing equipments• Manage JDE Edward entries for the following: PM Model Work Order, PM Scheduler, New Parts Entry for equipment, Equipment Hierarchy, and Bill of Materials• Develop and update Bill of Materials for existing and new equipments• Interim Maintenance Planner for the Critical Systems department• Respond to equipment failure emergencies by troubleshooting and supervising maintenance technicians• Manage outside contractors for inspections, day to day maintenance work, and shutdown activities• In addition to the day to day responsibilities, the following are projects that I led and implemented:-Predictive Technologies Program that includes the following: Thermography, Vibration, Ultrasonic, Oil Analysis-Developed and implemented the plant’s Reliability Engineering Standard Operating Procedure (SOP).
  • United States Gypsum
    Process / Controls Engineer
    United States Gypsum Jan 2005 - May 2008
    Los Angeles
    • Designed and implemented process improvements for safety, cost savings, and efficiency. Also provided electrical and controls consultation for electrical department. This include: Tank temperature controls, Agitation, PaperTech High Speed Camera System, Drive Controls (Siemens and Allen Bradley), Field devices such as proximity sensors, level controls, flowmeters, magmeters, pressure transducers, etc. (Rosemount and Foxboro), Flow controls such as wafer, knife gate, and ball valves (Dezurik)• Developed and implemented capital projects that range from 100,000 to 1.4 million dollars. Projects include safety upgrades, repair and replacement, cost reduction, and moving and razing. This involves performing the initial ground work for engineering, design, technical layout, failure analysis, and implementation. -Projects Include: Rewinder Automation, with regenerative drive, 42” Refiner Automation, Conveyor Installation, Steam and Condensate Improvements, Well Rehabilitation, Web Break Detection System, DC to AC Motor and Drive Upgrade, Machine Integration, and Upgraded Cleaning Systems• Troubleshoot and address daily process issues. Supported plant technical process maintenance, such as PLCs, OPC servers, Wonderware, and Allen Bradley Control Logic.• Supported basic drive maintenance, both Siemens and Allen Bradley.• Administrative Duties Include:-Interim Paper Mill Department Manager -Interim Engineering Manager -Generated contracts for projects and monthly reports -Conducted monthly safety meetings with plant personnel -Managed the paper mill’s capital project plan-Performed cost saving analysis. This includes savings with power reduction on motors, water usage, and other raw materials.• Supported machine maintenance and reliability• Supervise maintenance personnel and contractors on projects and daily maintenance.• Commended by management team for improving mill process by effectively troubleshooting chronic issues
  • Pepsi Bottling Group
    Operations Intern
    Pepsi Bottling Group Mar 2005 - Dec 2005
    Riverside, Ca
    • Developed Lockout and Tagout Safety Protocols for all plant machineries and support systems to comply with U.S. Department of Labor Occupational Safety and Health Administration (OSHA) standards. Standards involved proper activation or energization of machines and energy control procedures. Inspected and analyzed machine’s power sources, such as electrical, pneumatic, and hydraulic systems, for proper operation and maintenance. • Developed and organized power panel layout of all plant machineries and support systems for maintenance use. • Assisted Maintenance Manager and Supervisor troubleshoot system malfunctions using PLCs (Programmable Logic Controllers)• Performed bottle line auditing • Performed asset verification• Effectively completed projects within schedule and made a great impact in plant safety and machine reliability

Mark Hernandez Skills

Gmp Root Cause Analysis Change Control Manufacturing Capa Validation Pharmaceutical Industry Standard Operating Procedure Quality System Fda

Mark Hernandez Education Details

Frequently Asked Questions about Mark Hernandez

What company does Mark Hernandez work for?

Mark Hernandez works for Theragent Inc

What is Mark Hernandez's role at the current company?

Mark Hernandez's current role is Director, Facilities and Engineering at Theragent.

What is Mark Hernandez's email address?

Mark Hernandez's email address is ma****@****nce.com

What is Mark Hernandez's direct phone number?

Mark Hernandez's direct phone number is +121344*****

What schools did Mark Hernandez attend?

Mark Hernandez attended California State Polytechnic University-Pomona.

What skills is Mark Hernandez known for?

Mark Hernandez has skills like Gmp, Root Cause Analysis, Change Control, Manufacturing, Capa, Validation, Pharmaceutical Industry, Standard Operating Procedure, Quality System, Fda.

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