• Author and Develop User Requirements Specification (URS) • Author and Complete System Risk Assessment (SRA) for Facility, Utility, Equipment, System and Analytical Instrument • Author and Complete System Impact Assessment (SIA) for Facility, Utility, Equipment, System and Analytical Instrument • Support and Collaboration with Process Engineering, Facilities and Calibration Services Teams • Author and Execute Qualification Protocol and Final Report • Development and… Show more • Author and Develop User Requirements Specification (URS) • Author and Complete System Risk Assessment (SRA) for Facility, Utility, Equipment, System and Analytical Instrument • Author and Complete System Impact Assessment (SIA) for Facility, Utility, Equipment, System and Analytical Instrument • Support and Collaboration with Process Engineering, Facilities and Calibration Services Teams • Author and Execute Qualification Protocol and Final Report • Development and Implementation of SOPs for Equipment/Systems Operation, Calibration and Planned Maintenance procedures for new Facility Startup • Review and/or Approve Requirement, Assessment, Protocol and Qualification Supporting Documentation and SOPs • Complete Requirements Traceability Matrices (RTM) to support Qualification Testing Fulfillment to URS • SME, Author and Execution of Air Flow Visualization (AFV) Studies for BSC/Clean Environment Systems • Participate in Weekly Engineering Projects Team Meetings • Represent CQV/Engineering in Site Tier 3/Tier 4 Leadership Huddles as Requested by Management • SME for Facilities/Engineering as CQV Liaison through new facility Commissioning and Startup. Show less

(MilliporeSigma / SAFC Carlsbad)Carlsbad, CA:• Oversight and Management of Preventative Maintenance Program, including routine, Monthly Quality and Quarterly Business Review Metrics.• Scheduling and Coordination of cGXP Facilities, Utilities, Equipment and Systems Preventative Maintenance, Service and Repair Activities with MFG Planning and Lab Crew Management Teams.• Manage Service Agreements for Equipment, Systems and Instruments used for cGXP application, including… Show more (MilliporeSigma / SAFC Carlsbad)Carlsbad, CA:• Oversight and Management of Preventative Maintenance Program, including routine, Monthly Quality and Quarterly Business Review Metrics.• Scheduling and Coordination of cGXP Facilities, Utilities, Equipment and Systems Preventative Maintenance, Service and Repair Activities with MFG Planning and Lab Crew Management Teams.• Manage Service Agreements for Equipment, Systems and Instruments used for cGXP application, including Service Supplier Qualification activities and ongoing review as part of QA Supplier Quality Management Program.• Support and Collaboration with Validation and Calibration services Teams.• Key Project Team Leader in the upgrade of Blue Mountain, Regulatory Asset Manager to R3 SP6.• Development and Implementation of Planned and Unplanned Maintenance Tracking and Communication Tools.• Led Maintenance and Facilities Engineering Team meetings and participated in Daily MFG Meetings as representative of Maintenance and Facilities Engineering Team.• Audit Support as Facilities Operations SME, including Audit Observation Response and Development of CAPAs.• Event-Deviation Management SME and support to Deviation Investigation and Root Cause Analysis. Show less

(MilliporeSigma / SAFC Carlsbad)Carlsbad, CA:• Worked as an SME on Multi-Disciplinary, Core Management Project Team in the Design, Conceptualization and Specification of new Large Scale, 500 - 2000L Manufacturing Cleanroom Facility Expansion ($80MM Capital Project), housed within ~120k Sq. Ft. of building shell space for contract manufacture of Viral/Gene Therapy Medicines.• Provided supporting Design Details for Floorplan, ISO/EU Grade Cleanroom Space Classification, Flow… Show more (MilliporeSigma / SAFC Carlsbad)Carlsbad, CA:• Worked as an SME on Multi-Disciplinary, Core Management Project Team in the Design, Conceptualization and Specification of new Large Scale, 500 - 2000L Manufacturing Cleanroom Facility Expansion ($80MM Capital Project), housed within ~120k Sq. Ft. of building shell space for contract manufacture of Viral/Gene Therapy Medicines.• Provided supporting Design Details for Floorplan, ISO/EU Grade Cleanroom Space Classification, Flow, Pressurization, Materials of Construction and Utilities.• Review and Approval of submittals and workup for Utility Systems and Equipment such as Electrical, GenSet, HVAC, Steam, Purified Water, Waste Drainage, etc.• Provided details in support of MFG, Laboratory and Warehouse Equipment and Systems such as Biological Safety Equipment (BSCs and LFH), Controlled Room Temperature Warehousing and Controlled Temperature Units, etc.• Provided oversight and review on application of Building Automation/Management Systems and Critical Environment Monitoring Systems and Networking Infrastructure.• Engaged in corporate EHS Audit, including follow-up Corrective/Preventive Actions.• Leader in Engineering Team support to Multi-Disciplinary, Client Project Teams for Pre-Process Qualification activities as part of existing site business. Show less

(MilliporeSigma / SAFC Carlsbad)Carlsbad, CA:• Member of Core Leadership Management, Project Team responsible for enabling the first FDA Approved Viral/Gene Therapy medicine.• Direct experience in multiple Regulatory Audits as an SME, presenting to agencies such as FDA and EMA as well as Client Audits that include various former FDA and Consultant Group auditors.• Led Multi-functional Teams in support of Equipment/Facilities Validation Lifecyle Management Practices in a… Show more (MilliporeSigma / SAFC Carlsbad)Carlsbad, CA:• Member of Core Leadership Management, Project Team responsible for enabling the first FDA Approved Viral/Gene Therapy medicine.• Direct experience in multiple Regulatory Audits as an SME, presenting to agencies such as FDA and EMA as well as Client Audits that include various former FDA and Consultant Group auditors.• Led Multi-functional Teams in support of Equipment/Facilities Validation Lifecyle Management Practices in a highly technical, emerging technology marketplace.• Management of (12) Direct Reports and (3) Contracted Services Personnel.• Management of Validation Program Services, including Assessment, Review and Approval of Equipment and Facilities Qualification Protocols and Final Reports.• Management of Calibration Program Services, including Assessment and Review of Calibration Documentation, Certification and Reports.• Management of Facilities Services, which includes the oversight and development of Pest Control Program, building and office upkeep, Janitorial Programs and Cleanroom Decontamination Cleaning Services, Fire Systems Maintenance Services and Monitoring Dispatch, etc.• Management of Preventive Maintenance Program Services which includes oversight and development of cGMP Equipment, Facilities and Equipment/Systems Maintenance Programs, Assessment and Review of Certification Documentation and Service Reports.• Integral Project Team Member in support of Engineering Department through Multi-Building Site Expansion ($9MM Capital Project), in the addition of ~9K sq. ft. of Modular Cleanroom build, 4,500 sq. ft. of cGMP Warehouse space and Process Development Lab Expansion. Show less

(SAFC Carlsbad)Carlsbad, CA:• Supervision of Calibration Program Activities and Development.• Supervision of Facilities Inspections and Operational Activities.• Personnel Supervision of (3) Direct Reports.• Supervision of Maintenance Program Operational Activities.• Assistant Manager of Building Projects, working closely with Engineering Department Management in field construction activities and oversight.• Operational oversight of Building Automation/Management… Show more (SAFC Carlsbad)Carlsbad, CA:• Supervision of Calibration Program Activities and Development.• Supervision of Facilities Inspections and Operational Activities.• Personnel Supervision of (3) Direct Reports.• Supervision of Maintenance Program Operational Activities.• Assistant Manager of Building Projects, working closely with Engineering Department Management in field construction activities and oversight.• Operational oversight of Building Automation/Management and Critical Environment Monitoring Systems. Show less

(SAFC Carlsbad)Carlsbad, CA:• Hired as a direct full-time Employee, continuing as listed under contracted duties, while advancing in skills and experience.• Assisted Engineering Department Management in the Design Detail and Development of Dedicated Fill Room Expansion Project.• As part of prerequisite activities of the Fill Room Expansion Project, assisted Validation Supervisor with Autoclave/Steam Sterilizer review, oversight, acquisition and participated in Factory… Show more (SAFC Carlsbad)Carlsbad, CA:• Hired as a direct full-time Employee, continuing as listed under contracted duties, while advancing in skills and experience.• Assisted Engineering Department Management in the Design Detail and Development of Dedicated Fill Room Expansion Project.• As part of prerequisite activities of the Fill Room Expansion Project, assisted Validation Supervisor with Autoclave/Steam Sterilizer review, oversight, acquisition and participated in Factory Acceptance Testing at Steris/FinAqua in Helsinki, Finland.• Authored and Executed Autoclave Load Validation Studies. Show less

(SAFC Carlsbad)Carlsbad, CA:• Contracted to provide full-time support during 6211 Lab Facility Relocation Project, through 6219 MFG Facility Commercial Expansion Project.• Provided services such as cGXP Equipment, Facilities, Utilities and Systems Maintenance and Repair.• Calibration• Validation• cGMP Documentation, SOPs, Validation Protocol, Validation Final Report, Deviation Investigation, Author and Execution.• Electrical, Electronic, Telecom, Network and… Show more (SAFC Carlsbad)Carlsbad, CA:• Contracted to provide full-time support during 6211 Lab Facility Relocation Project, through 6219 MFG Facility Commercial Expansion Project.• Provided services such as cGXP Equipment, Facilities, Utilities and Systems Maintenance and Repair.• Calibration• Validation• cGMP Documentation, SOPs, Validation Protocol, Validation Final Report, Deviation Investigation, Author and Execution.• Electrical, Electronic, Telecom, Network and Software Controls Installation and Configuration.• Blue Mountain Calibration Manager / Regulatory Asset Manager (CMMS), Application Setup, Configuration, Implementation, and Systems Administration.• General Building, Repair and Fabrication.• Engineering Support, Special Project and Construction Management. Show less

San Diego, CA:Cooper Electric performs Electrical Service, Installation and Construction with a focus in the Biotech and Pharmaceutical Industries.• Commercial - Pharmaceutical, Biotech, New Construction and Tennant Improvement.• Starting Position as Electrical Service Technician, working/training under Texas State Licensed, Master Electrician - Karl Hicks.• Performed Electrical Tasks, Rough-In, Ceilings, Branch Circuiting, Piping, Wire Pulls, Etc.• Familiar with… Show more San Diego, CA:Cooper Electric performs Electrical Service, Installation and Construction with a focus in the Biotech and Pharmaceutical Industries.• Commercial - Pharmaceutical, Biotech, New Construction and Tennant Improvement.• Starting Position as Electrical Service Technician, working/training under Texas State Licensed, Master Electrician - Karl Hicks.• Performed Electrical Tasks, Rough-In, Ceilings, Branch Circuiting, Piping, Wire Pulls, Etc.• Familiar with Machinery, Equipment Wiring, Hook-Up and Troubleshooting of various industrial and lab equipment such as Mass Spectrometer, Steam Sterilizer, Biological Safety Equipment, MRI, Air Handling Systems and HVAC, Chillers, Boilers, Lift Truck, etc.• Certified California State Licensed, General Commercial Electrician.• Graduated to Foreman Level.• Managed Service Calls/Jobs Independently, as well as Full Scale Construction Projects with direct, customer-facing communication, planning and scheduling, including supervision of up to 6 Electricians on Job Site.• Telecom and Network Wiring Installation.• Installation, Troubleshoot and Repair of Machinery and Equipment Control Systems, Pump Control and Advanced Lighting Control. Show less

San Diego, CA:Worked as apprentice level electrician performing general duties such as refrigeration systems installations, lighting installations and maintenance in commercial buildings, offices and laboratories, electrical conduit (EMT) and panel service feed installation, rough-in walls and ceilings and large equipment electrical installations.

Anaheim, CA:Assisted and worked under a journeyman electrical foreman on large new construction projects and independently performed routine electrical working tasks while developing further electrical trade skills such as wire pulls/cuts, electrical conduit (EMT) and raceway bends, assembly, and installation and metal clad (MC) cabling runs.

Anaheim, CA:Worked in the construction of commercial/industrial concrete tilt-up type structures and tenant improvement projects. Performed tasks in the capacity of reading blueprints, constructing concrete form structures, foundation groundwork, leveling and application of surveying equipment, wood and steel stud framing, operation of heavy equipment and skilled operation of measurement devices, hand and powered tools.

Chino, CA:Performed investigation including undercover surveillance, tracking, identification and reporting in collaboration with insurance agencies in support of insurance claims and fraud investigation cases.

Corona, CA:Refurbished, fabricated and prepared laser equipment and other electronic technologies such as HeNe, Argon, NdYAG and other multi-gas tube laser equipment, laser diode, night vision, optics, power supply and laser light show equipment and systems for sale/resale. Shipped orders and handled stock/inventory and parts supply to maintain warehousing operations. Provided customer-facing technical service and sales support for a diverse range of products.