Position Summary

The Manufacturing Specialist I/II is responsible for supporting equipment and cGMP operations for the Upstream team in a large-scale biopharmaceutical facility. The manufacturing specialist has experience in upstream unit operations (see expansion, bioreactor operations, cell culture harves), and a working knowledge of upstream equipment. The incumbent will have knowledge of general bioprocessing equipment and disposable technologies. The manufacturing specialist possesses proven technical writing and problem-solving skills and a drive for continuous improvement.

From a technical perspective, the manufacturing specialist is responsible for system ownership activities such as generating manufacturing procedures and records, procuring and enrolling manufacturing equipment, defining equipment maintenance requirements, and supporting equipment commissioning and qualification activities. They will also drive operational excellence initiatives and perform other activities required of system owners.

From a compliance perspective, the manufacturing specialist is responsible for performing thorough and robust manufacturing investigations, implementing effective corrective/preventative actions, and managing manufacturing change controls.

The manufacturing specialist is responsible for working cross-functionally with the manufacturing departments, QA, MS&T, engineering, supply chain, IT, AFS, and other key departments to ensure manufacturing operations are successful, reliable, and compliant.

Positions Responsibilities

• Generate and revise manufacturing documents such as electronic manufacturing records, logbooks, process flow charts, risk assessments, and equipment and facility procedures for specific manufacturing process units
• Manage manufacturing materials and equipment: Design and enroll manufacturing assemblies, enroll and set-up new equipment, support equipment maintenance, execute commissioning/qualification activities, perform change control assessments, ensure appropriate equipment maintenance, and perform vendor coordination
• Perform manufacturing investigations, problem solving, root cause analysis. Implement process improvements, CAPAs, change controls, and safety improvements
• Support activities associated with Operational Excellence Initiatives including: error proofing, standardization, 5S, Lean manufacturing

Position Requirements

• Specialist I: B.A./B.S. in a Life Sciences or Engineering degree and 2+ years of relevant experience or equivalent education and experience
• Specialist II: B.A./B.S. in a Life Sciences or Engineering degree and 4+ years of relevant experience or equivalent education and experience.

Salary: Specialist I: $49,274-$67,752

Specialist II: $62,400-$85,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. 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, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

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.