Manufacturing Execution System (MES) Engineer I/II

Job Summary

The Manufacturing Execution System (MES) engineer on the MES operations team will support the startup and ongoing manufacturing operations at a biopharmaceutical manufacturing facility. The individual will report to the Associate Director of MES Operations. The individual will be responsible for being a MES system specialist for the site. The ideal candidate will have experience with pharmaceutical manufacturing execution and automation systems. Experience with MES software is required (MODA-ES is HIGHLY desired). Familiarity with SQL, typescript/javascript, and Excel Macros is desired. Relevant experience with Allen Bradley PLC’s, OSI PI Historian, SQL Server, and SAP 4/HANA is a plus. 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.

Position Responsibilities

• Generation and revision of system lifecycle documentation associated with electronic manufacturing records and logbooks such as Functional/Design/Configuration Specifications, process and data flow charts, supporting risk assessments, and supporting equipment and facility procedures for specific manufacturing process units, as needed.
• Generation and revision of electronic manufacturing records and electronic logbooks within the MES platform, including impact/coordination for associated interfaces and databases, as well as support for testing and qualification activities, as needed.
• Requires routine interface with Manufacturing/MS&T to develop electronic records in alignment with process requirements and specifications.
• Supports system ownership tasks such as performing change control assessments, ensuring appropriate system maintenance is setup and executed, and supporting vendor coordination for system support and upgrades.
• Manages assigned change controls to ensure system is maintained in a compliant manner.
• Technical input to manufacturing investigations, problem solving, and root cause analysis.
• Ownership for implementing identified process improvements, CAPAs, Change Controls, and Safety Improvements as it relates to MES/IT platform.
• Develop, maintain, and deliver training programs for system end-users and create comprehensive documentation for MES processes and procedures (Use, Navigation, Access, etc.).
• Experience with the Agile framework and/or Scrum process, such as a team member in an Agile setting, is preferred.
• Experience with JIRA or SNOW applications are a plus.

Position Requirements

• B.A./B.S. in a Life Sciences or Engineering degree and/or 4-8 years relevant experience or equivalent education and/or experience.
• Previous experience as an MES Engineer or equivalent role is required.

KBI Biopharma, Inc.

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.