Manufacturing Specialist I​/II, Downstream

Manufacturing Specialist I/II, Downstream

Join to apply for the Manufacturing Specialist I/II, Downstream role at KBI Biopharma
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This position will provide technical support activities for GMP Manufacturing Operations in a multi-product, large‐scale biopharmaceutical facility. The role supports:

• Drafting, routing, and revision of manufacturing batch records, procedures, and supporting records.
• Manufacturing process support during ongoing shop floor execution, when required.
• Support new equipment enrollment efforts from purchasing to qualification activities.
• First line of defense for manufacturing events, assessing the event and providing immediate corrective actions.
• Lead implementations for corrective and preventive actions.
• Point of contact for laboratory equipment supporting manufacturing operations, troubleshooting, vendor calls, equipment repair coordination, operational changes, and system qualifications.
• Support safety initiatives, compliance, and quality requirements.

• Generation of batch records, solution records, equipment preparation records, processing assembly records, test sampling plans, and process flow charts for specific manufacturing process units.
• Manufacturing laboratory equipment: work order initiation and follow‑up, assessments to support deviations, troubleshooting, and vendor coordination.
• CAPA and change control implementations, safety improvement implementations.
• Manufacturing operation support and troubleshooting.
• Support activities associated with Operational Excellence Initiatives including error proofing, standardization, 5S, and lean manufacturing.

• Specialist I:
  High School Diploma with 5+ years of related industry experience (Downstream/Purification operations preferred);
  Bachelor’s Degree in a related scientific or engineering discipline preferred with 2+ years of related industry experience;
  Master’s degree in a related scientific or engineering discipline preferred with 0+ years of related industry experience.
• Specialist II:
  High School Diploma with 8+ years of related industry experience (Downstream/Purification operations preferred);
  Bachelor’s Degree in a related scientific or engineering discipline preferred with 4+ years of related industry experience;
  Master’s degree in a related scientific or engineering discipline preferred with 2+ years of related industry experience.

• Read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Write routine GMP documents.
• Speak effectively in front of internal groups.

• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

• Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Compute rate, ratio, and percent and draw and interpret bar graphs.

• May be exposed to moving mechanical parts.
• May be occasionally exposed to caustic chemicals and risk of electrical shock.
• Noisy environment: low to moderate noise level.

• Knowledge or prior experience using MS Office Software, Electronic Document Management Systems, and E‑mail.

• Knowledge and experience using equipment such as Office equipment, biosafety cabinets, incubators, single‑use bioreactors, chromatography columns/skids, ultrafiltration systems, drug substance filling operations, peristaltic pumps, and other single‑use pumps.

KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401(k) matching, and employee recognition programs.

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers…