Description

You will provide technical expertise and strategic direction for sterilization processes while supporting production stability.

Responsibilities

• Troubleshoot production upsets and implement corrective actions to reestablish operations.
• Develop SPC/SQC protocols to improve process discipline and control.
• Lead sterilization activities including development, validation, routine sterilization, and requalification.
• Analyze process data for trends and monitor asset performance to maintain 98% uptime.
• Document all process changes through the formal change control process.
• Train maintenance and operations personnel on machinery and process workflows.

Required Skills

• Bachelor’s degree in Engineering, Material Science, Physics, or a related physical science.
• 0-3 years of experience in engineering or manufacturing environments.
• Proficiency in MS Word, Excel, and PowerPoint.
• Experience with data analysis software such as JMP or Minitab.
• Strong experimental practices and engineering problem-solving skills.
• Ability to apply engineering first principles to drive mechanistic understanding and root cause identification.
• Capacity to participate in a rotating off-hours call schedule for process upsets or downtime.

Preferred Skills

• Experience in Life Sciences or medical device industries with knowledge of sterility assurance.
• Familiarity with radiation, heat, filtration, or chemical sterilization methods and ISO standards.
• Background in DMAIC or lean manufacturing principles.

Key Skills

Education

Bachelor's degree