Job Description

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/owner 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), Allen Bradley PLC’s, OSI PI Historian, SQL Server, and SAP 4/HANA is desired. Familiarity with SQL, typescript/javascript, 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 system ownership activities such as generating electronic logbooks and electronic manufacturing production records, authoring functional and design 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 providing technical input to thorough and robust manufacturing investigations, implement effective corrective/preventative actions, and manage manufacturing change controls. This will ensure Quality compliance and regulatory requirements are met for GMP production.

The individual is responsible for working cross-functionally with the manufacturing departments, QA, MS&T, engineering, supply chain, QC 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 system lifecycle documentation associated with electronic manufacturing records and logbooks such as Functional/Design/Configuration Specifications, process and data flow charts, risk assessments, and equipment and facility procedures for specific manufacturing process units.
• 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.
• System ownership tasks such as performing change control assessments, ensuring appropriate system maintenance is setup and executed, performing vendor coordination for system support and upgrades, and ensuring vendor support agreements are established and maintained. Managing 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.).
• The Senior MES Engineer will provide mentoring and leadership to other engineers within the team and assigned to projects.
• Experience as an Agile SCRUM Master, Product Owner, or team member in an Agile setting is preferred.
• Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing.
• Solid and thorough understanding of GMP applications and associated regulatory requirements (including 21 CFR Part 11, Data Integrity, etc.).
• Knowledge of the IT system development life cycle and software quality assurance in a regulated environment. Knowledge of general networking concepts and IT best practices.
• Ability to work both independently and with teams at various levels in the organization.

Position Requirements:

• B.A./B.S. in a Life Sciences or Engineering degree and/or 9+ years relevant experience or equivalent education and/or experience.
• 5+ years previous experience as an MES Engineer or equivalent role is required

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.