About this role
Process/Instrumentation engineer supporting engineering, calibration, and change management for a manufacturing site with emphasis on process documentation and regulatory compliance.
Key Responsibilities
- Process Definition and Documentation through PFDs, P&IDs, SOPs, and training
- Calibration Administration and CCMS entry
- Support change controls and deviations
- Develop Process Flows and diagrams
- Support biological processes and packaging
Technical Overview
Focuses on process definition, instrumentation, calibration systems, and integration of process control across fermentation, fill, and packaging operations with CAD and CPPD collaboration.
Ideal Candidate
An entry-level process/instrumentation engineer with 0-3 years of experience who can define processes, manage calibration, and support regulatory compliance in a biopharmaceutical production setting.
Must-Have Skills
0-3 years of relevant industry experienceProcess Engineer or Calibration Administrator or Automation Engineer or Instrument Engineer background preferredAdaptabilityData AnalysisInstrumentationProcess OptimizationProject ManagementTeamworkTechnical CommunicationInstrument Engineering
Nice-to-Have Skills
CAD ProficiencyReading P&IDsDomestic travelGxP experienceRegulatory compliance knowledgeBiopharmaceutical production experience
Required Skills
AdaptabilityBiopharmaceutical OperationsCAD ProficiencyData AnalysisEngineering PrincipleEngineering StandardsEstimation and PlanningExperimentationInstrumentationInstrumentation EngineeringProcess OptimizationProfessional EngineeringProject ManagementSoftware ProficiencySystem ControlTeamworkTechnical CommunicationTechnical Problem-Solving
Hard Skills
Process DefinitionPFDP&IDSOPProcess DocumentationCritical Parameter HierarchyCalibration AdministrationCalibration Management SystemProcess Flow DiagramBlock DiagramRegulation interpretationDeviation InvestigationRoot Cause AnalysisData AnalysisCADComputerized Calibration Management System administrationChange ControlsFermentationConcentrationSterile FillingFreeze DryingSerializationPackaging
Soft Skills
AdaptabilityData AnalysisTeamworkTechnical CommunicationProblem Solving
Keywords for Your Resume
associate specialistprocess and instrumentation engineerprocess definitionpfdpidsopcalibrationcalibration system administratorcritical parameterscritical attributescritical process parameterscalibration management systemccmschange controldeviation investigationroot cause analysisdata analysiscadcomputerized calibration management systemfermentationbiopharmaceutical operationsgxp21 CFR Part 11regulatory complianceregulatory affairsprocess engineercalibration engineercalibration administratorPFDP&IDSOP
Deal Breakers
Bachelor's degree in engineering required, 0-3 years of relevant experience
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