Engineer, GMP Production Line Support & Automation JP

Engineer, GMP Production Line Support & Automation

3 Key Consulting is hiring an Engineer (GMP Production Support) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

• Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope.
• Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.
• Assist with project definition by performing engineering studies and assessment for automation system installations.
• Perform field evaluations of existing systems and provide engineering design recommendations.

• 1–2+ years of hands-on experience in a GMP-regulated environment
• Work In teams, communication
• Mechanical systems experience

• Monitor daily operations of production lines.
• Assist with troubleshooting downtime related issues, manage line improvements, work through CAPAs and deviations.

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

• Previous intern experience is a plus.
• Experience with automation is a plus.
• Experience with computer programming, systems, and/or robotics is a plus
• Experience working in an FDA-regulated environment
• Familiarity with maintenance management software (e.g., Maximo)
• Experience with 3D modeling tools such as Solid Works or similar
• Strong technical writing skills

Opportunity to gain experience working in an FDA and GMP regulated environment.

• Inability to meet core job requirements.
• Poor communication skills.
• Unable to work OT as needed.
• Flexibility is required as workload increases.

One on one - Panel interview