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Senior MES Engineer Summary

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Senior MES Engineer is a key technical role within INCOG BioPharma Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control strategies, and support the technology road map.  The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries.

The Senior MES Engineer will have expertise in SCADA systems, MES platforms, process controls, plant automation, digital technologies, and engineering principles. You will have demonstrated ability to apply experience to process design, design thinking, data integrity, controls, instrumentation, industrial enterprise systems, and data analytics. You must be able to partner and lead internal partners, customers, A&E firms, GCs, OEMs, and suppliers to provide unified engineering solutions.  Additionally, you must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.

Essential Job Functions:

Enterprise Systems and Data

·       Lead and support the implementation, configuration, and ongoing management of Manufacturing Execution System (MES) platforms to ensure seamless integration with process automation, batch management, and quality systems.

·       Familiarity and understanding of ISA-88 and ISA-95 models.

·       Support plant SCADA, Historians, Distributed HMI applications, Alarms and Events, Audit Trails, and Automation interfaces including Rockwell Factory Talk and OPC based platforms.

·       Leverage big data tools and analytics platforms to aggregate, analyze, and visualize manufacturing process data, enabling trend identification, process optimization, and real-time operational visibility.

·       Partner with Quality and Operations teams to utilize data from MES, historian, and databases in support of deviation investigations, process monitoring, and continued process verification (CPV) programs.

·       Provide technical support to Computer System Validation (CSV) activities, including MES qualification and data integrity assessments.

·       Work closely with IT to implement OT solutions in an integrated and secure network.

Project Support

·       SME for implementation of technology, automation, and OT infrastructure projects.

·       Evaluate new technology and process automation for introduction into GMP manufacturing.

·       Provide technical support to FAT, SAT,  and Computer System Validation (CSV) activities.

·       Partner with vendors and suppliers to define requirements and understand functional specifications.

Controls, Operation, and CI Support

·       Resolve issues that arise in day to day running of automated systems and providing timely responses and solutions, including PLC, HMI, SCADA, Historian, reporting, and OT systems.

·       Implement process control solutions in collaboration with cross-functional technical teams and site leadership team.

·       SME for site process automation architecture and automated process control solutions in accordance with process requirements.

·       Configuring new automated processes and objects using workflow principles that are efficient, well structured, sustainable, and easy to understand.

·       SME for automation of technical cross-functional teams to advance production.

·       Evaluate and improve efficiency of manufacturing technologies, instruments, equipment, and tools.

·       Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.

·       Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.

·       Work flexible hours to ensure production facility coverage.

Special Job Requirements:

·       Bachelor’s degree in engineering field, computer science, or life sciences.

·       5+ years of relevant work experience.

·       Demonstrated hands-on experience with Manufacturing Execution Systems (MES) in a GMP-regulated manufacturing environment.

·       Experience working with big data platforms, historian systems, or data analytics tools in an industrial or pharmaceutical manufacturing context.

Additional Preferences:

•             Advanced degree or PE.

•             Formulation and batch processing.

•             Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices.

•             Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development.

•             Demonstrated experience with Rockwell PharmaSuite MES, including configuration, electronic batch record (eBR) development, and integration with plant automation systems in a GMP environment.

•             Experience integrating OT systems such as MES, OEE, and SCADAs with automation layer, ERP, and LIMS systems in a regulated environment.

•             Familiarity with analytics and reporting tools such as Microsoft SQL Server, SSRS, Optix, Seeq, Fabric, PowerBI, or similar manufacturing intelligence platforms.

•             Experience in statistical analysis using JMP or Minitab.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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