Manufacturing Specialist

Madison, WI

Instant Apply

30+ days ago

Job Description

Summary:
Seeking a Manufacturing Technical Support / Deviations Specialist with experience in GMP biologics manufacturing, technical troubleshooting, deviations, CAPA, change controls, and process improvement. The role supports clinical and commercial manufacturing and works closely with Manufacturing, Quality, Process Development, QC, Engineering, and other cross-functional teams.
Roles & Responsibilities:

Provide real-time technical support and advanced troubleshooting for GMP manufacturing processes.
Support deviations, investigations, CAPA, and change controls, including root-cause analysis and impact assessment.
Draft and revise SOPs, batch production records, reports, and other GMP documentation.
Support process data analysis, trending, technical reports, and client presentations.
Work cross-functionally on technology transfer, facility fit, process scaling, and process validation.
Identify opportunities for process and equipment improvements, efficiency gains, and waste reduction.
Support biologics manufacturing processes including upstream cell culture, downstream purification, chromatography, TFF, buffer preparation, and filtration.
Troubleshoot manufacturing equipment, including single-use systems, bioreactors, chromatography systems, and filtration equipment.
Apply GMP, quality risk management, FMEA, and other compliance practices.
Work in a cleanroom/cGMP manufacturing environment and support late-phase/commercial manufacturing activities.

Required Qualifications:

5+ years of relevant experience in biopharmaceutical/biologics manufacturing or technical support.
STEM degree: Associate's, Bachelor's, or Master's with relevant industry experience.
Strong experience with GMP documentation, SOPs, batch records, deviations, CAPA, and change controls.
Experience with process equipment troubleshooting and single-use manufacturing systems.
Knowledge of upstream/downstream processing and biologics manufacturing.
Experience with data analysis, statistical techniques, and process trending.
Ability to use Microsoft Office and manufacturing/compliance systems such as TrackWise, ComplianceWire, or Unicorn.
Strong communication, problem-solving, technical writing, and cross-functional collaboration skills.

Numbers & Facts

Location

Madison, WI

Skills

Biological Processesunmatched
Cell Culturesunmatched
Change Controlunmatched
Chromatographic Systemsunmatched
Chromatographyunmatched
Cleanroomunmatched
Clinical Supportunmatched
Communication Skillsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Analysisunmatched
Data Processingunmatched
Documentationunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
GMP (Good Manufacturing Practices)unmatched
Identify Issuesunmatched
Manufacturingunmatched
Manufacturing Equipmentunmatched
Manufacturing Systemsunmatched
Manufacturing Technologyunmatched
Manufacturing/Industrial Processesunmatched
Microsoft Officeunmatched
Problem Solving Skillsunmatched
Process Analysisunmatched
Process Developmentunmatched
Process Improvementunmatched
Process Validationunmatched
Quality Controlunmatched
Quality Managementunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Sales Presentationunmatched
Standard Operating Procedures (SOP)unmatched
Statisticsunmatched
Team Playerunmatched
Technical Supportunmatched
Technical Writingunmatched
Trend Analysisunmatched
Unicorn Library Management Systemunmatched

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