Process Engineer I in Miami

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Job DescriptionJob DescriptionDescription:

Job purpose

The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.

Duties and 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.

Requirements:

Qualifications

Qualifications include:

• BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.
• 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.
• Strong knowledge of LEAN manufacturing principles .
• Working knowledge of 21 CFR 1271 regulations and AATB guidelines .
• Proficient in project planning software. Microsoft Project .
• CTBS certified (or certified within two years of employment).
• Strong work ethics.

Working conditions

Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing.

Physical requirements

The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans.

Direct reports

No direct reports

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