Jonathan Gendron, Cfm, Fmp Email & Phone Number

Marlborough, Massachusetts, United States

Cambridge, 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.

Plainville, 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.

Boston, Massachusetts

National 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.

Burlington, 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.

Mattapan, Massachusetts

Cambridge, Massachusetts

Framingham

Participated 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.

Cambridge, Massachusetts

Facilities Management And Operations Certificate, Facilities Management

Diploma, Engineering