Equipment Engineer II: Drive Process Improvements

Regenity Biosciences; Allendale (NJ); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Company performance bonus eligibility

401(k) plan with company contribution

Paid time off and paid holidays

Medical, prescription, dental, and 
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Company-paid life and AD&D insurance

Wellness Program and EAP

Tuition Reimbursement

Job summary

Regenity Biosciences seeks an Equipment Engineer II to support manufacturing operations and validation activities, driving safety, productivity, yields, and cost efficiency. The role requires a solid understanding of manufacturing processes and equipment, with the ability to contribute to strategic and operational objectives in a regulated environment.

The ideal candidate will perform commissioning/qualification of new equipment, write SOPs, troubleshoot issues, and work with R&D to transfer

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent required.
• Experience in a regulated industry (Medical Device/Pharma/ISO 9000+) preferred.
• Strong writing and detailed document-review abilities.
• Ability to manage change and learn新 concepts quickly.
• Excellent verbal and written communication; able to work in a team.

Responsibilities

• Perform commissioning and qualification of new equipment.
• Prepare and review equipment qualification reports.
• Write or revise standard operating procedures.
• Participate in new equipment design, selection, startup and optimization.
• Troubleshoot equipment performance issues incl. root cause analysis.
• Transfer new equipment into manufacturing with R&D and others.
• Evaluate processes and propose improvements or fixes.
• Work independently or with other engineers/scientists.
• Improve overall equipment reliability across manufacturing operations.
• Troubleshoot/optimize packaging and filling equipment for throughput and cost.
• Program software and perform software validation on various equipment.
• Manage large-scale equipment projects with a team.

Skills

Problem solving

Strong communication

Self-starter

Team player

Documentation

Education

Bachelor's degree in Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Regenity Biosciences seeks an Equipment Engineer II to support manufacturing operations and validation activities, driving safety, productivity, yields, and cost efficiency. The role requires a solid understanding of manufacturing processes and equipment, with the ability to contribute to strategic and operational objectives in a regulated environment.

The ideal candidate will perform commissioning/qualification of new equipment, write SOPs, troubleshoot issues, and work with R&D to transfer