Principal Automation & MES Engineer - Site based, Redmond, WA

Evotec•Redmond, WA

2d•$134,000 - $154,100•Onsite

About The Position

The Principal Automation & MES Engineer is responsible for the design, implementation, optimization, and lifecycle management of Manufacturing Execution Systems (MES), process automation systems, and digital manufacturing technologies within a regulated manufacturing environment. This role serves as a senior technical leader supporting enterprise manufacturing operations, operational excellence initiatives, and digital transformation strategies across manufacturing sites. While MES technologies are a primary area of responsibility, this position is broader in scope and includes leadership in automation architecture, systems integration, process control strategy, validation, governance, and manufacturing systems modernization. The ideal candidate combines deep technical expertise with strong engineering leadership, cross-functional collaboration, and strategic thinking to deliver scalable and compliant manufacturing solutions. This role will partner closely with Manufacturing, MSAT, IT, Quality, Validation, Engineering, and external system integrators to drive innovation, maintain system reliability, and support expansion of advanced manufacturing capabilities.

Requirements

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 Manufacturing Execution Systems (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.

Nice To Haves

Experience supporting global manufacturing operations or Center of Excellence (CoE) initiatives.
Experience with continuous manufacturing, single-use systems, or advanced bioprocessing technologies.
Knowledge of data historians, analytics platforms, and industrial networking concepts.
Experience with cloud-connected manufacturing systems and digital transformation initiatives.
Prior involvement in regulatory inspections and audit support.
Experience managing or mentoring engineering teams and technical resources.
PMP, Lean Six Sigma, or automation/manufacturing certifications are a plus.

Responsibilities

Lead the design, configuration, deployment, and continuous improvement of MES solutions to support manufacturing operations, electronic batch execution, data integrity, and operational efficiency.
Support integration of MES platforms with enterprise and site systems including ERP, LIMS, historians, SCADA/DCS, CMMS, and data analytics platforms.
Define and maintain MES governance, standards, lifecycle management practices, and system roadmaps aligned with business objectives.
Participate in enterprise digital manufacturing initiatives and support implementation of Industry 4.0 capabilities including process data integration, automation connectivity, and advanced manufacturing analytics.
Provide technical leadership for automation and process control systems including DeltaV, SCADA, PLC, HMI, and related manufacturing control platforms.
Support development and implementation of automation strategies for manufacturing processes, utilities, and process equipment.
Lead or support complex troubleshooting, root cause investigations, deviation investigations, and corrective actions related to manufacturing automation and MES systems.
Evaluate and implement innovative technologies to improve manufacturing flexibility, reliability, and process performance.
Lead integration efforts between manufacturing systems and enterprise applications to ensure reliable and compliant data flow across the manufacturing ecosystem.
Develop and review system architectures, functional specifications, design documents, and interface strategies for manufacturing technologies.
Provide oversight of external vendors, system integrators, and contractors supporting manufacturing systems projects.
Support cybersecurity, data integrity, disaster recovery, and infrastructure reliability initiatives related to manufacturing systems.
Ensure manufacturing systems remain compliant with GMP, FDA, GAMP5, and 21 CFR Part 11 requirements.
Author, review, and approve validation documentation including URS, FRS, DS, IQ/OQ/PQ protocols, risk assessments, traceability matrices, and test scripts.
Support regulatory inspections, audits, and quality investigations related to manufacturing systems and automation platforms.
Drive adoption of risk-based validation methodologies and continuous improvement of CSV and SDLC practices.
Lead or contribute to capital projects, system implementations, upgrades, migrations, and site expansion initiatives.
Develop project scopes, schedules, resource plans, and technical execution strategies for manufacturing systems projects.
Coordinate cross-functional teams and stakeholders to ensure project deliverables, timelines, budgets, and quality expectations are achieved.
Provide technical and strategic input into long-term manufacturing technology planning and operational roadmaps.
Identify opportunities to improve manufacturing efficiency, data visibility, system reliability, and process robustness through automation and MES enhancements.
Drive standardization and harmonization of manufacturing systems across sites and programs where applicable.
Support development of KPIs, system performance metrics, and reporting capabilities to enable data-driven decision making.
Stay current on emerging technologies, industry trends, and best practices in MES, automation, and digital manufacturing.
Serve as a subject matter expert for MES, automation, validation, and manufacturing systems engineering.
Mentor junior engineers and provide technical coaching across automation and manufacturing systems disciplines.
Influence engineering standards, governance processes, and best practices across the organization.
Lead technical reviews, design discussions, and strategic engineering initiatives with senior stakeholders.