Job Description

Position Summary:

The manufacturing execution system engineer on the technical support and investigations team will support the startup and ongoing manufacturing operations at a new biopharmaceutical manufacturing facility. During startup the individual will be responsible for supporting the introduction and qualification of the MES system at the facility. The individual will report to the director of technical support and investigations.

The individual will be responsible for being one of the MES system specialists for the site. The ideal candidate will have experience with pharmaceutical manufacturing execution and automation systems. Familiarity Allen Bradley PLC’s, OSI PI Historian, SQL Server, and Inventory Tracking Systems is desired. Familiarity with SQL, C-like syntax, and Excel Macros is also desired. Additionally, experience in support or operations for the startup and ongoing operations for a commercial GMP mammalian cell culture facility is highly desired.

The engineer should possess proven technical writing and problem-solving skills and a drive for continuous improvement. Additionally, experience with manufacturing deviation, CAPAs, and change controls in a GMP manufacturing facility is desired.

From a technical perspective, the individual will be responsible for supporting MES activities such as generating electronic logbooks, generating electronic manufacturing records, generating functional specifications, setting system standards, providing system training and expertise, and owning and managing system change controls and upgrades.

From a compliance perspective, the individual will be responsible for performing thorough and robust manufacturing investigations, implement effective corrective/preventative actions, and manage manufacturing change controls.

The individual 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. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.

Position Responsibilities:

• Generation and revision of documentation associated with electronic manufacturing records and logbooks such as functional specifications, process flow charts, risk assessments, and equipment and facility procedures for specific manufacturing process units.
• Generation and revision of electronic manufacturing records and electronic logbooks and supporting testing and qualification activities.
• System ownership tasks such as performing change control assessments, ensuring appropriate system maintenance is setup and executed, performing vendor coordination for system support, upgrades and also ensuring vendor support agreements are established and maintained. Managing change controls to ensure system is maintained in a compliant manner.
• Performing manufacturing investigations, problem solving, root cause analysis, and implementing process improvements, CAPAs, Change Controls, and Safety Improvements.
• Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing

Position Requirements:

• B.A./B.S. in a Life Sciences or Engineering degree and 0-2+ years relevant experience or equivalent education and experience.

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.

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.