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.

From a technical perspective, the individual will be responsible for supporting system 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 supporting 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 support/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 MES 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, 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.
• 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.
• Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing.
• 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 4-8 years relevant experience or equivalent education and/or experience.
• Previous experience as an MES Engineer or equivalent role is required.