Avantor · 1 week ago

Process Engineer II

Pennsylvania, United States

Full-time

Onsite

Senior Level

7+ years exp

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BiotechnologyElectronics

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Responsibilities

Optimize manufacturing processes to meet quality and regulatory standards.

Utilize data analysis and simulation tools for process evaluation and improvement.

Collaborate with cross-functional teams to develop new processes and equipment specifications.

Manage project scope, objectives, deliverables, milestones, and resources.

Write and review process documentation including batch records, SOPs, protocols, reports, and risk assessments.

Travel domestically up to 50% for project-related activities.

Qualification

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Process DesignOptimizationTroubleshootingData AnalysisSimulationStatistical ToolsQuality StandardsRegulatory RequirementsGMP GuidelinesScaling UpTransferring Manufacturing ProcessesProcess CharacterizationValidationReviewing Process DocumentationProject Management MethodologiesDefining Project ScopeObjectivesDeliverablesMilestonesResourcesSchedulingMonitoringReporting Project ActivitiesExperience in Manufacturing EnvironmentEngineering CapacityCollaboration Tools (Microsoft Office)Aspen PlusSuperPro DesignerSimSci Pro/IIAnalytical Methods

Required

Bachelor's degree in chemical engineering, process engineering, or related field.

Process design, optimization, control, and troubleshooting.

Data analysis, simulation, and statistical tools to evaluate process performance and identify improvement opportunities.

Quality standards and regulatory requirements for chemical products.

GMP guidelines and practices for chemical and biological processes.

Designing, developing, scaling up, and transferring manufacturing processes from lab to pilot to commercial scale.

Process characterization, optimization, validation, and troubleshooting using statistical tools and techniques.

Writing and reviewing process documentation, such as batch records, SOPs, protocols, reports, risk assessments, etc.

Project management methodologies, tools, and best practices.

Defining project scope, objectives, deliverables, milestones, and resources.

Planning, scheduling, monitoring, controlling, and reporting project activities and status.

Experience in a manufacturing environment, in an engineering capacity involving chemical process design, transfer design input for manufacturability and capital funds request preparation.

Collaboration Tools (IE: Microsoft Office)