The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields and reduce variation. This position performs equipment qualifications and process validations. 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

• Generate and execute protocols to perform equipment qualifications and process validations.
• Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements.
• Lead efforts to solve problems using formal problem resolution techniques and root cause analysis.
• Create and communicate project plans with detailed tasks and timelines necessary for project completion.
• Develop equipment and process validation protocols (IQ, OQ, PQ) and reports.
• Lead and perform equipment qualifications and process validations as needed.
• Develop and monitor process and equipment metrics to use for optimization analysis.
• Other duties as assigned.

• Bachelor’s degree in Biomedical 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, and problem solving skills.
• Ability to effective communicate with multidisciplinary teams.
• Excellent technical writing.
• Preferred: Strong knowledge of LEAN Manufacturing principles.
• Preferred: working knowledge of 21 CFR 1271 regulations and AATB guidelines.
• Proficient in project planning software. Microsoft Project preferred.
• Knowledge in CAD software preferred.

Working Conditions

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 occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs.

Direct Reports

Intern

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time.