Night Shift Bioprocess Operator (Cell Culture)

KBI Biopharma, Inc.; Durham (NC); On-site; USD 42,000 - 64,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I - Nights to perform upstream or downstream production activities for cell culture programs in a GMP environment.

Responsibilities include executing tasks per SOPs, batch records, and GDP/GMP/GLP standards, ensuring compliance and accuracy. The role requires a Bachelor's degree in a related scientific or engineering discipline (0-2 years GMP experience) or a high school diploma with 3-5 years GMP experience, fluent English, and strong

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 0–2 years of GMP manufacturing experience; OR high school diploma with 3–5 years of GMP manufacturing experience.
• Fluent in English (reading and writing).
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of employees.
• Reasoning ability: solve practical problems with varying data.
• Ability to interpret instructions furnished in written, oral, diagram, or schedule form.
• Math ability: perform arithmetic with whole numbers, fractions and decimals.

Responsibilities

• Manufacture cell culture products according to batch records and quality standards.
• Perform cleanroom operations with aseptic processing controls and gowning procedures.
• Document manufacturing procedures (SRs, EPRs, BRs) per GDP.
• Maintain issuance and accountability of items in manufacturing records.
• Apply cGMP knowledge in daily tasks.
• Maintain 5S standards in the manufacturing environment.
• Operate and maintain equipment per SOPs.

Skills

English fluency

Reading documents

Writing reports

Speaking before groups

Reasoning ability

Math abilities

Education

Bachelor's degree in a related scientific or engineering discipline

High school diploma with GMP experience

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I - Nights to perform upstream or downstream production activities for cell culture programs in a GMP environment.

Responsibilities include executing tasks per SOPs, batch records, and GDP/GMP/GLP standards, ensuring compliance and accuracy. The role requires a Bachelor's degree in a related scientific or engineering discipline (0-2 years GMP experience) or a high school diploma with 3-5 years GMP experience, fluent English, and strong