Facility Engineer

Facility EngineerThe Facility Engineer is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be responsible developing, testing, modifying, and creating solutions to technical problems.Essential Duties & ResponsibilitiesFollow safety rules and regulations as per OSHA and other applicable agenciesEnsure proper maintenance of facility equipment / utilities to ensure equipment runs smoothlyMonitor for and ensure proper pest control activity in the facilityHandle validation and calibration activities for Biologics operations from writing documentation such as protocols, test scripts, deviations, draft SOPs, support calibration, alarms and risks assessment to field execution to collect samples for QC testing, cycle development studies, thermal mapping, troubleshooting, deviation resolutions, evaluating and compiling test data, preparing reports and obtaining its approvalProvide corporate level technical support and implement long-range reliability improve programsGenerate engineering documents for equipment, facility and utilities, and execute the same (project execution, vendor development)Complete new equipment selection and installation as per project requirementsPerform Thermal Mapping on various biomedical freezers and refrigerators using Kaye ValidatorImprove teamwork efficiency by implementing technically possible correctionsMaintain documentation as per company's requirement / GMP requirementsMaintain all HVAC systems, associated equipment, electrical equipment, plumbing systems and BMSCreate AutoCAD drawings, perform load calculations using Trace 700 and assist with BM SinstallationManage and maintain Lab Gas supply demand, monitor the alarms and inventory, and change the tanks as requiredParticipate in design of architectural, electrical, plumbing, fire protection and HVACManage the Asset ID list for equipment in use and in warehouse. Manage transportation of the equipment back and forth to warehouse and facility as requiredMaintain and update the PM Master Schedule and Master Calibration list as requiredPrepare the PM details and master calibration for equipment and utilities and coordinate the PM/Calibration activityPrepare presentation materials, calculations, construction documents, design analysis, and completion of projectsManage shipping and receiving and manage timely approval for outstanding invoicesCoordinate with external vendor for the PM and Master Calibration List and other maintenance tasks asMaintain and coordinate the update of the floor plans and P&ID of the equipment and facility in AutoCAD or Solid worksEnsure proper sanitization of the facility interior and exteriorDaily monitoring of the BMS system and coordination with external vendor as requiredDaily monitoring of the utilities and equipment and maintenance of the log bookPrepare and update the Engineering SOP as requiredSupport construction and project related activityManage all EHS programs (Environmental, Industrial Hygiene, Safety, Waste Management, and Personal Protective Equipment), regulations, processes, and initiativesManage all hazardous and biological waste. Streamline the waste management processCollaborate with Manufacturing, Analytical Research and Development, Quality Assurance, Microbiology, Engineering, Supply Chain and Human Resources on a regular basis to ensure consistent application of EHS programs and positive outcomes for the organizationPerforms other functions as required or assignedComplies with all company policies and standardsRequirementsPosition Requirements and QualificationsEducation:Bachelor's degree in Engineering, Mechanical Engineering, Electrical Engineering, or related field preferredExperience:Minimum 1-3 years engineering experience in GMP environmentExperience with OSHA, EPA, FDA, and local authority jurisdictions requiredSpecialized Knowledge And Skills:Excellent oral and written communication skills requiredAbility to work independently with minimal direct supervision requiredComputer literate and proficient in Microsoft Word, Excel, Outlook, Project, PowerPoint, etc. requiredAdaptable, open to change and able to work in ambiguous situations and respond to new information and unexpected circumstances requiredDemonstrated attention to detail requiredAbility to effectively engage employees requiredStrong interpersonal and teamwork skills including the ability to easily convey concepts and priorities to peers, customers, leadership, and cross-functional teams requiredWork Environment & Physical Demands:General Work Environment:Office plus small scale manufacturing site.Ability to use and wear safety protective gear/equipment (e.g. safety glasses, hard hat, lab coat, gloves, respirator, etc.) and follow safety guidelines.Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.Ability to work nights and weekends as neededNoise:Possible moderate noise levels due to construction.Standing/Lifting:Ability to sit for an extended period.Ability to stand for extended periods of time and up to 6 hours at a time.Ability to climb ladders, walk on uneven surfaces, make observations and assessments from elevated heights consistent with those typically found on construction sitesConstant walking or motion to coordinate work and interact with co-workers.Ability to lift and move up to 40 pounds on an occasional basis.Visual:Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.Stress:High paced demanding environment to meet ambitious project goals.Travel:Minimal travel to be expected, but not to exceed 25%.Supervisory Responsibility, if any: NoThis position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.