Engineer, GMP Production Line Support & Automation

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.

Job Description:

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.

Top Must Have Skills:

1–2+ years of hands-on experience in a GMP-regulated environment

Work In teams, communication

Mechanical systems experience

Day to Day Responsibilities:

Monitor daily operations of production lines.

Assist with troubleshooting downtime related issues, manage line improvements, work through CAPAs and deviations.

Basic Qualifications:

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

Preferred Qualifications:

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 SolidWorks or similar

Strong technical writing skills

Employee Value Proposition:

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

Red Flags:

Inability to meet core job requirements.

Poor communication skills.

Unable to work OT as needed.

Flexibility is required as workload increases.

Interview process:

One on one - Panel interview