Vivex Biologics · 2 months ago
Process Engineer I
Miami,FL,US
Full-time
Onsite
Entry Level
1+ years expVivex 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
Required
BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline
1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role
Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills
Ability to effectively communicate with multidisciplinary teams
Excellent technical skills and writing
CTBS certified (or certified within two years of employment)
Strong work ethics
Preferred
Advanced degree (Master's) a plus
Strong knowledge of LEAN manufacturing principles
Working knowledge of 21 CFR 1271 regulations and AATB guidelines
Proficient in project planning software. Microsoft Project preferred
Company
Vivex Biologics
VIVEX Biologics' mission is to provide regenerative product solutions that help patients suffering from musculoskeletal injuries and wounds.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Agle
President & COO Legacy Donor Services Foundation
Tim Ganey
Chief Science Officer
Recent News
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