Jonathan Gendron, Cfm, Fmp Email and Phone Number
QUALIFICATION HIGHLIGHTS:• Over 15 years of successful experience in GMP manufacturing facilities and engineering management. • Expertise in project management within GMP facility construction, commissioning, and operational phases.• Experienced in optimizing operations of GMP manufacturing of vaccine, mRNA, and immunotherapy products.• Able to provide clear direction, clarify objectives, coach, and mentor employees and build high-performing teams.• Practiced in vendor management and using various procurement systems for asset and capital expense purchases.• Excels at troubleshooting and safely coordinating the resolution, repair and/or replacement of facility equipment.• Skilled in using Lean Six Sigma and continuous improvement to enhance performance and increase productivity.• Well-versed in FDA regulations, cGMP guidelines, and regulatory compliance in drug product manufacturing.• Seasoned in evaluating deviations, conducting root cause analyses, and implementing CAPAs to improve quality.• Experienced with writing/editing P&IDs, SOPs, Work Orders, submittals, proposals, and PM/Calibration schedules.• Adept at collaborating with cross-functional teams including quality, procurement, and other key stakeholders.• Natural critical thinker with an aptitude for overcoming challenges and obstacles by designing practical solutions.• Strong budget management acumen with exceptional leadership, communication, and relationship building skills. • Results-oriented, diligent, self-motivated, organized, learning agile, and a solution provider. KEY COMPETENCIES:Facilities Management • Facilities Engineering • GMP Manufacturing • Project ManagementTeam Leadership • Vendor Management • Budget Management • Quality AssuranceRegulatory Compliance • Inspection Readiness • Lean Six Sigma • Continuous Improvement Deviations • CAPAs • Root Cause Analysis (RCA) • Field Acceptance Testing (FAT)Site Acceptance Test (SAT) • Out of Place Testing • Hazard Assessments • Risk AssessmentsGap Assessments • Global Safety Standards • Equipment Calibrations • Preventative MaintenanceLaboratory Facilities • CDMO Operations • Procurement Systems • CMMS SystemsVaccines • mRNA Products • Immunotherapy Products
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Corporate Project Engineer (East Coast, Us)The Tjx Companies, Inc. Jul 2024 - PresentMarlborough, Massachusetts, United States -
Senior Manager Of Gmp FacilitiesGsk Feb 2023 - Jun 2024Cambridge, Massachusetts, United States• Manage and maintain a 100K ft2 shared vaccine manufacturing facility with 250+ employees including 30K ft2of GMP manufacturing and lab space.• Lead, coach, and develop a team of three FTE’s and two contractors and organize and facilitate team building events.• Schedule and coordinate vendors/contracts for a 10K ft2expansion project of lab and manufacturing clean spaces. • Create and champion safety programs such as Permit to Work, Safe Start, Job Hazard Assessment, Risk Assessment, GAP Assessments, Lockout Tagout, and Global Engineering Safety Standards. • Manage unplanned events and deviations using initial impact assessments, recurring analysis, root cause investigations, final impact assessments, and corrective and preventative actions (CAPA).• Serve as a key stakeholder on the FAT and SAT team for internal QA audits and FDA auditors. • Manage the commissioning and validation of WFI Generation and Distribution, Lab HVAC, and Lab Compressed Air. • Create, revise, and implement SOPs such as Site Access, LOTO, Alarm Response, and WFI Operation and Sanitization. • Work closely with Procurement teams for complementary workers, capital, and operational related expenses. • Manage contractors and vendors via SAP Fieldglass and Fiori and use Ariba Guided Buy and SAP for asset purchases.• Key Accomplishments:- Participated in a new site acquisition as well as the coordination of equipment and personnel transfers.- Increased headcount and interviewed and hired 10+ FAC/ENG team members to support a growing site. - Created, manage, and participate in the Emergency On-Call Support Program. - Traveled for Mechanical and Process Safety Masterclass and FAT’s and SATs in Singapore, Italy, and Belgium. -
Facilities And Engineering ManagementThermo Fisher Scientific Jan 2021 - Feb 2023Plainville, Massachusetts, United States• Led the facility operations for vaccine, mRNA, and immunotherapy GMP manufacturing facilities for a large CDMO.• Hired, managed, and developed a team of 12 facilities professionals as the first Facilities hire for the site.• Oversaw facilities for a 300K ft2 manufacturing facility and developed and managed the facilities operational budget.• Implemented and enforced iAuditor safety walks, procedures, and PPE policies.• Performed Life Cycle Analyses, Spare Parts Assessments, Instrument Impact Assessments, Purchase Order Requisitions/Approvals, and departmental Cash-Flow Analyses.• Supported Out of Place Testing, FATs, Process Engineering, and Metrology at various Thermo Fisher sites.• Collaborated with cross-functional groups to write, revise, and approve newly implemented site-specific SOPs.• Created and delegated work orders via the Blue Mountain Regulatory Asset Management system.• Served as SME for BWT Clean Steam and WFI, WasTech BioKill and pH Neutralization, BeliMed Autoclaves, Steris VHP and CamFil Bi-Bo systems supporting the site.• Utilized iAuditor, ProCore, Workday, Catalyst, Ariba, Documentum, Kneat, Delta V, MetaSys, and SuccessFactors.• Key Accomplishments:- Provided vendor management during the construction, commissioning, and start-up phase of Project Atlas. - Fielded proposals, quotes and EAF submittal’s amounting to approximately $500K for initial startup activities.- Coordinated and implemented Smart Building projects and initiatives including an advanced Aircuity system, a BIOXstream X-1000 Macerator, energy recovery systems, and ongoing solar/wind energy projects.- Won numerous awards, accolades, and recognitions based on performance, attitude, and flexibility. -
Facilities ManagementBoston University Jan 2015 - Dec 2020Boston, MassachusettsNational Emerging Infectious Diseases Laboratories (NEIDL)• Managed Biocontainment, Facilities, and Operations for a 195K ft2 Biosafety Lab Level 2, 3, and 4.• Served as Team Lead for a team of 7 Facilities professionals providing guidance, coaching, and development.• Ensured adherence to strict CDC and BPH guidelines regarding the safety and operation of a BSL-2, 3, and 4 facilities.• Assisted Lab personnel with the repair, maintenance and/or replacement of critical lab equipment.• Performed rounds, work orders, and preventative maintenance outlined via FastField and iMPulse CMMS program. • Monitored and maintained air pressure resistant barrier doors, back-up breathing air, compressed air, decontamination shower systems, RODI, clean steam humidification, wastewater, and effluent discharge system.• Performed calibrations of BSL-4 differential pressure gauges, automated control valves, and Effluent pH probes. -
Sr. Facilities SpecialistAmri (Albany Molecular Research Inc.) Oct 2014 - May 2016Burlington, Massachusetts• Coordinated and delegated calibration, preventative maintenance (PM), and Work Orders via Cal-Man System. • Managed vendors and scheduled equipment calibration and assisted Facilities Technicians with maintenance.• Collaborated with vendors and contractors issuing Purchase Orders, estimated quotes, and cost control. • Generated weekly and monthly Work Orders for all calibrations and PMs related to company equipment.• Updated the Cal-Man database with equipment changes, installations, repairs, removal of service, and calibrations.• Worked in Class A and 10k sterile suites to perform maintenance or calibrations on equipment. -
Facilities Specialist/First Class FiremanMassbiologics Feb 2014 - Jan 2015Mattapan, Massachusetts -
Lead Facilities TechnicianOpk Biotech Llc 2009 - Dec 2013Cambridge, Massachusetts
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Commissioning SuperintendentPcm Consulting Inc. Mar 2013 - May 2013Framingham
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Plant OperatorGreat Point Energy, Inc Sep 2007 - Jun 2009Participated in and oversaw Construction to Commissioning to Operation procedures per P&IDs and specifications.• Participated in successful fluidized bed operations, syn-gas production, safe and proper coal, and char discharge procedures, and utilizing of high pressure and low-pressure nitrogen for process requirements.• Created and updated MSDS books, SOP’s, O&M Manuals, and Commissioning Turnover Packages• Voluntarily took shift lead responsibilities when needed or called upon. This consisted of properly utilizing workgroups for successful completion of projects, attending management meetings, and ensuring everyone’s safety on shift.• Took charge of all necessary field operations such as troubleshooting, mechanical repairs or maintenance, inventory, cleaning, calibrating, and safety procedures.• Wrote reports for any notable activity within the plant directly to supervisors or management and distributed throughout operations to ensure proper communication.• Very fluent with flow diagrams, P&IDs, building specifications, electrical drawings, and modifying preliminary drawings.• Trained utility operators as well as interns, plant process, operations, and most importantly, safety.• Control room duties consisted of manual valve operation, flow, and temperature controls, troubleshooting DCS issues, monitoring nitrogen, hydrogen, sulfur dioxide, and argon levels, and basic value/set-point inputs. -
Facilities Team LeadBiopure Apr 2004 - Apr 2006Cambridge, Massachusetts
Jonathan Gendron, Cfm, Fmp Education Details
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Facilities Management
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Greater New Bedford Regional Vocational Technical SchoolEngineering
Frequently Asked Questions about Jonathan Gendron, Cfm, Fmp
What company does Jonathan Gendron, Cfm, Fmp work for?
Jonathan Gendron, Cfm, Fmp works for The Tjx Companies, Inc.
What is Jonathan Gendron, Cfm, Fmp's role at the current company?
Jonathan Gendron, Cfm, Fmp's current role is Accomplished Facilities and Engineering Leader with Expertise in GMP Manufacturing and Project Management.
What schools did Jonathan Gendron, Cfm, Fmp attend?
Jonathan Gendron, Cfm, Fmp attended Boston University, Greater New Bedford Regional Vocational Technical School.
Who are Jonathan Gendron, Cfm, Fmp's colleagues?
Jonathan Gendron, Cfm, Fmp's colleagues are Marianna Dendrinos, Ella Rose, Jonathan Mcdonald, Ronnie Lister, Joseph Schagene, Ebonie Powell, Alahna-Noelle Amoah.
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