Principal Automation & MES Engineer - Site based, Redmond, WA
$134,000–$154,100 year
On-site · Seattle, Washington, United States or Redmond, Washington, United States
Job Summary
Lead the design, configuration, deployment, and lifecycle management of MES and automation systems to support regulated manufacturing operations, including electronic batch execution, data integrity, and operational efficiency. Provide technical leadership for MES governance, integration with ERP/LIMS/historians/SCADA/DCS/CMMS, and support Industry 4.0 initiatives. Drive validation, risk-based approaches, and compliance with GMP, FDA, GAMP5, and 21 CFR Part 11. Lead or contribute to capital projects, collaborate with cross-functional teams, and mentor junior engineers while enabling scalable, compliant manufacturing technology across sites. Occasional travel to manufacturing sites and global locations may be required. Site-based role in Redmond, WA, and Seattle, WA.
Required Qualifications
- Bachelor’s or Master’s degree in Engineering, Computer Science, Biotechnology, Automation, or related technical discipline
- 10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
- Strong experience with MES platforms such as PAS-X, Syncade, PharmaSuite, Opcenter, or equivalent
- Experience with process automation platforms such as DeltaV, Siemens, Allen-Bradley, Wonderware, Ignition, or related technologies
- Demonstrated experience supporting validated manufacturing systems within GMP-regulated environments
- Strong understanding of FDA regulations, GAMP5, SDLC methodologies, and 21 CFR Part 11 compliance requirements
- Proven experience leading complex technical projects and cross-functional engineering initiatives
- Experience with system integration, manufacturing data flows, and enterprise application connectivity
- Strong analytical, troubleshooting, organizational, and communication skills
- Ability to work effectively across global teams, manufacturing sites, and external partners
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