GMP Facility Services
Engineering & Technical Services
Facilities, automation, and maintenance engineering keep a GMP site
qualified and running. Zymergi's engineering capabilities span clean
utility systems and HVAC through PLC/SCADA/DCS integration to the
calibration and preventive maintenance programs that underpin every
successful inspection.
Clean utility operation and maintenance — WFI, purified water, HVAC, compressed gasesCleanroom classification and environmental monitoring systemsFacility modifications, CAPEX projects, and preventive maintenance programscGMP and EHS facility complianceEquipment and utility qualification/validationHVAC and clean utility system design and operationBuilding codes and GMP facility requirementsCMMS platforms (Maximo, SAP PM, Blue Mountain)CAPEX project execution and budgetingMechanical and electrical troubleshootingPLC, SCADA, DCS, and MES system design, configuration, and maintenanceProcess control and automation strategy implementationData integrity and 21 CFR Part 11 compliance for automated systemsAutomation-related deviation troubleshootingComputerized system validation (CSV) and system lifecycle supportPLC/SCADA/DCS platforms — DeltaV, Siemens, Allen-BradleyGAMP 5 and CSV principlesInstrumentation and control loop tuningProgramming — ladder logic, structured text, function blocksProblem-solving in regulated manufacturing environmentsPreventive maintenance and calibration program execution for GMP equipmentCorrective repairs with full SOP-compliant documentationCalibration records management with NIST traceabilityMetrology and precision instrumentationGMP equipment maintenance practicesCMMS work order managementGet in touch —
let's start with a mutual confidentiality agreement.