Manufacturing Tech Associate I – Process Improvement

Bora Biologics USA LLC; Indianapolis (IN); On-site; USD 64,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Job summary

Bora Biologics USA LLC is seeking an Manufacturing Technology Associate I to support biopharmaceutical drug substance manufacturing. You will collaborate with Manufacturing Operations and Biopharmaceutical Development to enable technology transfers, validate processes, and support routine manufacturing at internal sites.

The role emphasizes deviation investigations, data-driven problem solving, and cross-functional teamwork to improve efficiency and product quality in a cGMP environment.

Qualifications

• Bachelor's degree in a life sciences or engineering field.
• Exposure to biopharmaceutical manufacturing and/or protein purification processes.
• Experience with Deviation, CAPA and Change Control systems.

Responsibilities

• Lead investigations of deviations to determine root cause and impact.
• Develop and implement corrective action plans at cGMP facilities.
• Perform data analyses and root cause analyses to identify solutions.
• Lead continuous process monitoring and apply statistical tools to improve productivity and robustness.
• Support technology transfer between internal and external sites.

Skills

Root cause analysis

Data analysis

Process improvement

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Chemical/Biochemical Engineering, Biology, Chemistry, Biochemistry or related life sciences or engineering field

Tools

Column chromatography

Titration & filtration

Microsoft Office

Job description

Bora Biologics USA LLC is seeking an Manufacturing Technology Associate I to support biopharmaceutical drug substance manufacturing. You will collaborate with Manufacturing Operations and Biopharmaceutical Development to enable technology transfers, validate processes, and support routine manufacturing at internal sites.

The role emphasizes deviation investigations, data-driven problem solving, and cross-functional teamwork to improve efficiency and product quality in a cGMP environment.