What are the responsibilities and job description for the Manufacturing Specialist I/II position at KBI Biopharma?
JOB SUMMARY
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.
JOB RESPONSIBILITIES
Responsibility Approximate % of Time Generation of batch records, solution records, equipment preparation records, processing assembly records, test sampling plans and process flow charts for specific manufacturing process units. 70% Manufacturing laboratory equipment: work order initiation and follow up, assessments to support deviations, troubleshooting and vendor coordination. 10% CAPA and Change Control implementations, Safety Improvement implementations. 10% Manufacturing operation executions. 5% Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing 5% Total: 100%
MINIMUM 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.
Physical Demands: While performing the duties of this job the employee may be exposed to moving mechanical parts. The employee may be occasionally exposed to caustic chemicals and risk of electrical shock. The noise level in the environment is low to moderate.
Computer Skills: MS Office Software, Electronic Document Management Systems, E-mail
Equipment Use: Examples include Office Equipment, Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography columns/skids, Ultrafiltration systems, drug substance filling operations, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, Other lab equipment, and other production equipment. Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, Other lab equipment, and other production equipment.
WORKING CONDITIONS
The job requires supporting a 24-hour manufacturing facility which may include oncall phone support or call in support overnight and on weekends. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee may use equipment and materials which include mechanical hazards, chemical hazards, electrical hazards, and tripping and falling hazards. The noise level in the manufacturing environment is moderate to high, however, employee will routinely work in office area.
Compensation Range:
$49,274 - $85,500 commensurate with experience
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Salary : $49,274 - $85,500
