Position Summary

• Assist with drafting, and revision of manufacturing batch records, procedures, and supporting records.
• Support new equipment enrollment qualification activities.
• Assist SMEs with laboratory equipment supporting manufacturing operations troubleshooting, vendor calls, equipment repair coordination, operational changes, and system qualifications.
• Support safety initiatives, compliance, and quality requirements on the GMP floor.

Position 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, follow up, assessments to support deviations, troubleshooting, and vendor coordination
• Support change control deliverable implementations, and CAPA action plans as needed
• Support compliance and quality activities with Operations Excellence Initiatives including: Standardization/5S and internal departmental auditing

Position Requirements

• High school degree or equivalent; Currently enrolled in an undergraduate or graduate program in Life Science, Engineering, or a related field.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficient in Microsoft Office Suite (Excel, PowerPoint, Word, and Visio).
• A demonstrated interest in the biopharmaceutical industry.
• Ability to work independently and as part of a team in a fast-paced environment.
• Able to stand on feet, bend, and move through cleanroom environment; able to lift equipment and samples. Must be comfortable working with hazardous materials and must comply to all health and safety regulations.

Salary Range: $15-$20/hour

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.