Onsite Automation Engineer

Posted 15 hours ago

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About the role

  • 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
  • short-term and long-term disability
  • company paid basic life insurance
  • 401k company match
  • generous paid time off and paid holiday
  • wellness and transportation benefits

Job title

Automation Engineer

Job type

Experience level

Mid levelSenior

Salary

$92,400 - $126,500 per year

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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