Manufacturing Specialist I/II, Upstream

KBI Biopharma•Durham, NC

7d•Onsite

About The Position

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility. This role will support, but not limited to the following: Drafting, routing, and revision of manufacturing batch records, procedures, supporting records. Manufacturing process support during on-going shop floor execution, when required. Support new equipment enrollment efforts from purchasing to qualification activities. First line of defense for manufacturing events. The candidate will assess the event and provide 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 & quality requirements.

Requirements

Knowledge, Skills, Abilities Specialist I: High School Diploma with 5+ years’ related industry experience (fermentation, cell culture, purification); Bachelor’s Degree in a related scientific or engineering discipline preferred with 2+ years’ related industry experience; Master’s degree in a related scientific or engineering discipline preferred with 0+ year’s related industry experience.
Specialist II: High School Diploma with 8+ years’ related industry experience (fermentation, cell culture, purification); Bachelor’s Degree in a related scientific or engineering discipline preferred with 4+ years’ related industry experience; Master’s degree in a related scientific or engineering discipline preferred with 2+ year’s related industry experience.
Language Ability Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
Ability to write routine GMP documents.
Ability to speak effectively on front of internal groups.
Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Computer Skills MS Office Software, Electronic Document Management Systems, E-mail

Responsibilities

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 troubleshooting and oversight.
Support activities associated with Operational Excellence Initiatives including Error Proofing, Standardization, 5S, Lean Manufacturing.