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Vivex Biologics · 2 months ago

Process Engineer I

Miami,FL,US

Full-time

Onsite

Entry Level

1+ years exp

Vivex Biologics is focused on improving manufacturing processes in the biologics field, and they are seeking a Process Engineer I to evaluate and enhance these processes. The role involves process design, validation, and optimization while ensuring compliance with industry standards.

BiotechnologyHealth CareTherapeutics

Responsibilities

Plan and execute process optimization, equipment qualification, and process validation or process qualification projects

Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements

Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports

Lead efforts to solve problems using formal problem resolution techniques and root cause analysis

Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan

Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team

Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards

Assess processes, take measurements, and interpret data

Develop and monitor process and equipment metrics to use for optimization analysis

Comply with FDA and AATB tissue banking standards

Other duties as assigned

Qualification

Biomedical EngineeringLEAN ManufacturingProject ManagementStatistical AnalysisProcess ValidationFDA RegulationsTroubleshootingWork EthicsMultidisciplinary TeamworkCTBS CertificationCritical ThinkingClear CommunicationProblem SolvingTechnical Writing