Automation Engineer designing and implementing MES solutions in a GMP-regulated biotech manufacturing environment. Collaborating with cross-functional teams for continuous improvement and system optimization.
Responsibilities
Design, configure, and implement MES solutions aligned with biotech manufacturing processes and GMP requirements
Develop and maintain electronic batch records (EBR), workflows, and recipes within the MES platform
Translate business and process requirements into functional MES configurations
Support integration of MES with enterprise and shop floor systems (e.g., ERP, LIMS, SCADA, historians)
Support design and implementation of process control strategies, including batch control, data acquisition, and process monitoring
Collaborate with automation teams on DeltaV and other DCS/SCADA systems used in bioprocessing control
Assist in maintaining validated automation systems, libraries, and standards in alignment with site and global practices
Contribute to integration between MES and control systems to enable seamless data flow and execution
Serve as a technical owner for assigned MES systems, modules, or functional areas
Support GMP manufacturing operations by troubleshooting issues, performing root cause analysis, and implementing fixes across MES and automation systems
Partner with Manufacturing and Quality teams to support batch execution, deviations, CAPAs, and process improvements
Ensure MES and automation solutions comply with GMP, FDA, and 21 CFR Part 11 requirements, with a focus on data integrity (ALCOA+)
Author, review, and execute validation deliverables (e.g., URS, FRS, IQ/OQ/PQ) in alignment with CSV/CSA and GAMP5 practices
Develop and maintain accurate, audit-ready documentation, including system configurations, SOPs, and training materials
Support internal and external audits and inspections
Lead technical workstreams or small-to-medium MES-focused projects; contribute to larger cross-functional automation initiatives
Participate in requirements gathering, system configuration, testing, and deployment activities
Support new product introduction (NPI) by ensuring MES and automation changes are designed, tested, and ready for manufacturing
Collaborate with stakeholders across Manufacturing, MSAT, Quality, IT, and Automation teams
Support implementation of digital manufacturing initiatives such as paperless manufacturing and review-by-exception
Identify and implement opportunities to improve manufacturing efficiency, quality, and data visibility using MES and automation systems
Contribute to system enhancements, standardization efforts, and adoption of global automation best practices
Act as an MES subject matter resource while contributing to broader automation knowledge within the team
Collaborate with global automation and MSAT teams to align on standards and best practices
Provide guidance to junior engineers and support knowledge sharing
Contribute to design reviews, troubleshooting efforts, and continuous improvement initiatives
Requirements
Bachelor’s degree in Engineering, Computer Science, or related technical field
5+ years of experience supporting or implementing MES in biotech, pharmaceutical, or other GxP-regulated environments
Hands-on experience with MES platforms (e.g., Werum PAS-X, Emerson Syncade, Rockwell PharmaSuite, Siemens OpCenter, or similar)
Experience building or supporting electronic batch records (EBR)
Strong understanding of GMP, FDA regulations, and 21 CFR Part 11
Experience supporting MES in a live manufacturing environment
Working knowledge of process control systems (e.g., DeltaV, SCADA/DCS) and automation integration
Strong troubleshooting, analytical, and problem-solving skills
Benefits
discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
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