Manufacturing Specialist I/II, Upstream

About the role

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. Assess the event and provide immediate corrective actions. Lead implementations for corrective and preventive 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.
• Safety initiatives, compliance & quality requirements.

Requirements

• 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.

Skills

• Knowledge of MS Office Software, Electronic Document Management Systems, E-mail.
• 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.
• 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.
• 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.

Benefits

• 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, 401K matching, and employee recognition programs.