Senior Manufacturing Engineer – Digital GMP Systems Lead

GeneFab; California (MO); On-site; USD 99,187 - 118,473; Full time

Job summary

GeneFab is seeking a Senior Manufacturing Engineer to manage production technology and digital systems in GMP manufacturing. This role involves leading the implementation of innovative production technologies, ensuring compliance with regulatory standards, and managing the lifecycle of critical manufacturing systems. Candidates should have extensive experience in biopharmaceutical environments, strong technical skills, and the ability to work in a fast-paced setting. This position is available as a contract engagement with potential for full-time employment based on performance and need.

Qualifications

• Minimum 8+ years of experience in pharmaceutical, biopharmaceutical, or cell/gene therapy manufacturing environments.
• 3+ years of experience managing production technology and digital manufacturing systems in a GMP environment.
• Strong understanding of 21 CFR Part 11 and GMP regulatory expectations.

Responsibilities

• Lead the identification and implementation of production technologies and equipment.
• Establish a process data historian to capture manufacturing data.
• Ensure compliance with 21 CFR Part 11 and GAMP 5 guidelines.

Skills

GMP manufacturing knowledge

Equipment data integration

Cross-functional collaboration

Technical writing

Education

Bachelor’s degree in Engineering (Biomedical, Chemical, Electrical, Mechanical)

Advanced degree (M.S. or Ph.D.)

Tools

EBR

LIMS

MES

AVEVA PI

InfluxDB

Job description

GeneFab is seeking a Senior Manufacturing Engineer to manage production technology and digital systems in GMP manufacturing. This role involves leading the implementation of innovative production technologies, ensuring compliance with regulatory standards, and managing the lifecycle of critical manufacturing systems. Candidates should have extensive experience in biopharmaceutical environments, strong technical skills, and the ability to work in a fast-paced setting. This position is available as a contract engagement with potential for full-time employment based on performance and need.