The Senior Automation Engineer provides subject matter expertise in the design, implementation, and lifecycle management of digital systems
Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing
Lead the creation, review, and approval of URS, FRS, DS / DDS, Functional & Control Narratives
Configure, program, and deploy Digital System within the manufacturing environment
Ensure all changes meet data integrity requirements, change control processes, and validation lifecycle rules
Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements
Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated system solutions

Requirements

Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related)
Minimum 9-12+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP)
Expert-level experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc)
Proven ability to author, interpret, and own URS/FRS/DS documentation
Experience designing system applications and data flows across the full spectrum of manufacturing applications
Strong understanding of ISA-88 batch control, ISA-95 manufacturing hierarchy, and GAMP5
Hands-on experience supporting biologics and sterile/aseptic manufacturing environments

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

automation engineeringsystem architecturedata flow designURS documentationFRS documentationISA-88ISA-95GAMP5troubleshootingsystem optimization

Soft Skills

collaborationleadershipcommunicationproblem-solvinganalytical thinking