James Gaines

James Gaines Email and Phone Number

Principal Consultant - CQV @ Bespoke Pharmaceutical
Temecula, CA, US
About James Gaines

OBJECTIVETo lead and develop fellow team members and project team in technical and soft skills that lead to overall project/company success and professional growth. Leading by example in technical knowledge of good engineering principles to allow for increased knowledge of all leading to success as a group and not just as individual contributors. ENGINEERING SKILLS• Project Management• Quality Assurance• Risk Assessments and Design Reviews• Project Lifecycle Documents• Operational Readiness• Safety • Building Commissioning (MEP)• Equipment Commissioning• Equipment Validation• FAT/SAT for HVAC, Process Skids, and Vessels• Blow-Fill-Seal Technician• cGMP and GXP• Controls Troubleshooting and Repair• Equipment Cleaning Validation• Preventative Maintenance• Temperature MappingLEADERSHIP SKILLS• Mentorship• Interpersonal Communication• Emotional Intelligence • Active Listening• Conflict Resolution• Integrity • Motivation• Empathy• Honesty

James Gaines's Current Company Details
Bespoke Pharmaceutical

Bespoke Pharmaceutical

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Principal Consultant - CQV
Temecula, CA, US
James Gaines Work Experience Details
  • Bespoke Pharmaceutical
    Principal Consultant - Cqv
    Bespoke Pharmaceutical
    Temecula, Ca, Us
  • Genentech
    Senior Qualification Manager
    Genentech Feb 2024 - Present
    South San Francisco, California, Us
    Clean utilities lead including process gasses and WFI for new commercial facility Clean and Dirty Utilities Commissioning and qualification using risk based qualification approachConstruction safety planning and field execution for facility and utility servicesWork permits, pre-task planning. Risk work planning and cross team coordination
  • Intuitive
    Senior Project Manager
    Intuitive Aug 2023 - Mar 2024
    California, 94086, Us
  • Cai
    Director Of Operations - Southern California
    Cai Jul 2021 - Jun 2023
    Indianapolis, Indiana, Us
    Oversaw projects and junior engineers in California at multiple client sites and project scopes ranging from new product lines, new facilities and process and site upgrades. Responsible for career, technical and personal development of 20-45 engineers across various stages of their career. Leadership at my own projects as SME and project manager providing on the job training in leadership and technical skills. Across the region responsible for championing professional development of junior engineers and preparing them for project work along with being available to assist technically at any time. Responsible for oversight of $1.5-3 million in project work. Drafted proposals in response to RFPs and sole source requests with a win rate of 62%.
  • Cai
    Commissioning Services Manager, Pacific Southwest
    Cai Jan 2021 - Jun 2023
    Indianapolis, Indiana, Us
    Responsible for expanding the Building Commissioning business area from $100,000 annually to over $500,000. Projects included tenant improvements of GMP production facilities along with non-GMP labs, vivarium’s, clinical testing facilities and medical device facilities. Served as Commissioning agent on projects commissioning scope ranging from $10,000-300,000 in direct sales. Expanded team from single person to group of 3 primary engineers along with cross training of most of the region on commissioning principles and execution.•Participated in facility improvements from conceptual design to owner handover while promoting safety and operational readiness.•Served as authorized owners’ representative during construction.•Performed Enhanced Commissioning for LEED requirements.•Perform generation, revision and execution of required documentation including pre-functional testing, functional performance testing, installation verification, installation operational and commissioning of facilities, site equipment and controls.•Served as SME for all systems where proficiency was demonstrated as validation engineer, operations engineer, commissioning engineer, or validation specialist.•Spaces including mixed use, research lab, vivarium, medical device production, clinical testing, QA/QC labs and commercial production. Systems included: HVAC (package and split systems), humidification/dehumidification, evaporative cooling, HHW, Condenser Tower Water, CRAC units, Exhaust fans, Chillers and chilled water systems, Industrial/domestic hot/cold/tepid water, WFI, RODI, soft water systems, Compressors and dryers for air systems, nitrogen storage and distribution, specialty gas systems, vacuum systems, solvent systems, waste systems, heat exchangers, electrical systems including generators and UPS systems, Building automation/management systems (Siemens and Jacobs), and environmental monitoring systems.
  • Cai
    Senior Commissioning And Qualification Engineer
    Cai Feb 2017 - Jan 2021
    Indianapolis, Indiana, Us
    • Generated and implemented validation master plan for site and project work including laboratory spaces.• Performed inspections of outside contractor work when related to maintaining site, facilities and equipment systems.• Lead installation and commissioning of laboratory equipment including benchtop COTS equipment and controlled temperature units.• Functional performance testing and cleaning validation to support commercialization of clinical facilities.• Autoclave performance qualification, temperature mapping and cycle development• Temperature mapping using Kaye, Lives and Elabs equipment for cryogenic freezers, controlled rate temperature units, incubators, walk in fridges and freezers, deli fridges, -80 and -20 freezers, ovens and controlled warehouses.
  • Cai
    Validation Specialist
    Cai Mar 2011 - Oct 2018
    Indianapolis, Indiana, Us
    • Led project manager for TOP generation and quality review. Responsible for facilitating commissioning and validation activities by ensuring documents meet all quality requirements and resolving any open issues.• Supervised a team of three contractors along with a 3rd party vendor team for FAT execution and review.• Assisted in quality review of documents during submittal process. Developed OQE standard for documentation type acceptance. Streamlined document deliverables for all phases of the project.• Assisted in generating and updating URS documents for the scope of the project.• Documentation and Execution team member for Functional Testing and Cleaning Validation to support commercialization of clinical facilities. Equipment included pumps, heat exchangers, tanks, chromatography skids, CIP skids, COP baths and Parts washers.• Project team member for building commissioning warranty qualification• Project manager for Winter Shutdown supervising two personnel, that included HVAC installs, Cold Room modifications and enhancements to WFI and PUR systems.• Performed database management of all files for the project including LEED, GMP and non-GMP. Assisted in quality review of documents during submittal process. Developed OQE standard for documentation type acceptance.• Member of HECP generation team for the entire facility to assist in transition from MAXIMO to SAP maintenance tracking program, including system walk-downs and P&ID updating and validation.• Performed Gap analysis on client records in response to FDA audit preparation.
  • Primapharma, Inc.
    Senior Operations Engineer
    Primapharma, Inc. Oct 2018 - Feb 2020
    • Establish a work environment characterized by mutual trust and respect, open and honest communications, teamwork and a passion for excellence through effective management, leadership models and techniques.• Participates in projects involving building maintenance, repairs and improvements including compressed air systems, HVAC systems, energy systems, electrical systems, process water systems and manufacturing equipment. Participation includes design, design review, attending meetings, investigating, attending FATs and applying engineering principles.• Performs inspections and surveillance of outside Contractor work when related to maintaining site and facilities equipment building systems.• Assists in the development and executes requirements related to facilities projects, facilities systems that support production, special projects, construction management and utilization of outside contractors.• Leads the design, installation and commissioning of plant facilities and equipment, plant utilities and associated control systems.• Performs generation and revision of required documentation to include SOPs for operation and maintenance of facilities and site equipment and controls.• Inspects buildings and facilities infrastructure to ascertain their condition and state of readiness. Support this effort by documenting the condition, deficiencies, recommendations and estimated cost of repairs. • Ensure that services and programs meet or exceed all Company and external regulatory authority requirements. Develop and maintain a consistent operational image, implementing initiatives and producing a quality product in accordance with Company standards. Ensure effective customer satisfaction, service and relations by implementing process and technology to deliver quality products and services.
  • Us Navy
    Reactor Control Division Leading Petty Officer
    Us Navy Dec 1998 - Feb 2011
    Washington, Dc, Us
    Nuclear Leading Petty Officer, Electronics Technician on submarines:• Supervised operation and maintenance of several nuclear power plants. Qualified Engineering Watch Supervisor.• As Electronics Technician Maintenance School (ETMS) Lead Instructor designed a new qualification standard for all ETMS platforms to ensure aggressive training and qualification and current systems knowledge.• Performed operations, testing and maintenance of the nuclear reactor plant, steam plant, instrumentation and control equipment and auxiliary interface systems.• Developed and approved work control procedures for maintenance and repair to electrical and electronic nuclear instrumentation and control equipment.• Maintained and authorized work/test authorization documents, reviewed completed work documents, reviewed work/test documents for actual interface and ship safety requirements.• Investigated and resolved test failures, and prepared, maintained, reviewed and certified work and test documents.• Managed a 5-8 person division performing electronic maintenance and repair on several various instrumentation suites.• Trained approximately 60 engineering department personnel and supervisors in all aspects of nuclear reactor operation and maintenance.Training: Navy Schools:• Navy Nuclear Power School and Prototype Training• Miniature Electronic Repair • Micro-Miniature Electronic Repair • Submarine Quality Assurance Inspector/Supervisor• Leadership and Management Seminars• Electronics Technician Maintenance• Instructor• Electronics Technician Maintenance Lead Instructor

James Gaines Skills

Quality Assurance Quality System Gmp Testing Validation Commissioning Troubleshooting Preventive Maintenance Nuclear Project Management Engineering Project Planning Computer System Validation Inspection Calibration 21 Cfr Part 11 Cleaning Validation Bcx Dcx Gxp

James Gaines Education Details

  • Devry University
    Devry University
    Concentration In Project Management
  • University Of Phoenix
    University Of Phoenix
    Project Management
  • Trinity Grammar And Prep
    Trinity Grammar And Prep
    High School Diploma

Frequently Asked Questions about James Gaines

What company does James Gaines work for?

James Gaines works for Bespoke Pharmaceutical

What is James Gaines's role at the current company?

James Gaines's current role is Principal Consultant - CQV.

What is James Gaines's email address?

James Gaines's email address is ja****@****nts.com

What is James Gaines's direct phone number?

James Gaines's direct phone number is +161988*****

What schools did James Gaines attend?

James Gaines attended Devry University, University Of Phoenix, Trinity Grammar And Prep.

What skills is James Gaines known for?

James Gaines has skills like Quality Assurance, Quality System, Gmp, Testing, Validation, Commissioning, Troubleshooting, Preventive Maintenance, Nuclear, Project Management, Engineering, Project Planning.

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