GMP Cell Therapy Equipment Engineer

ClinLab Solutions Group; Houston (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A biotechnology firm in Houston seeks a Maintenance Engineer to provide technical oversight for manufacturing equipment in the Cell Therapy and Viral Vector sectors. This role requires managing equipment lifecycle, establishing maintenance programs, and ensuring compliance with GMP regulations. The ideal candidate should possess a Bachelor's degree in Engineering and at least 7 years in the biotech industry, including experience in regulated manufacturing. Strong troubleshooting skills and attention to documentation are essential.

Qualifications

• 7+ years of relevant experience in biotech or life sciences.
• 4+ years in a regulated (GMP) manufacturing environment.
• Experience with cell therapy manufacturing equipment.

Responsibilities

• Provide technical ownership of GMP equipment throughout its lifecycle.
• Establish and improve preventive maintenance programs.
• Troubleshoot equipment issues and perform root cause analysis.
• Coordinate external service providers for maintenance and repairs.
• Document maintenance activities and update CMMS promptly.
• Author and execute qualification protocols in compliance with GMP.

Skills

Technical ownership of GMP equipment

Troubleshooting equipment issues

Preventive maintenance program development

Cross-functional collaboration

Equipment qualification and validation

Education

Bachelor's degree in Engineering or related field

Job description

A biotechnology firm in Houston seeks a Maintenance Engineer to provide technical oversight for manufacturing equipment in the Cell Therapy and Viral Vector sectors. This role requires managing equipment lifecycle, establishing maintenance programs, and ensuring compliance with GMP regulations. The ideal candidate should possess a Bachelor's degree in Engineering and at least 7 years in the biotech industry, including experience in regulated manufacturing. Strong troubleshooting skills and attention to documentation are essential.