Automation/Process Controls Engineer - Site MSAT, Redmond, WA

Role Summary

Automation/Process Controls Engineer on Site MSAT, Redmond, WA. Part of the Automation team in Global MSAT responsible for defining the automation (DeltaV) standards for the J.POD Manufacturing platform and providing automation support to Just-Evotec’s manufacturing sites. Design and implement automation solutions for a flexible and reconfigurable cGMP manufacturing facility focused on continuous processing, with advanced proficiency in DeltaV and experience in other automation platforms. GMP experience, change control, and automation validation per GAMP5 guidelines are highly preferred.

Responsibilities

• Participate in the design and implementation of automation and process control schemes to NPI processes, batch tracking, establishing process control limits, and applying predictive control algorithms.
• Maintain site level validated DeltaV library and participate at the site level governance and change management system for GMP changes and NPI implementation
• Participate in engagement with global MSAT Automation teams to support global and site objectives
• Develop or improve detailed specification, qualification (IQ/OQ/PQ), engineering, SOP, and training documents.
• Collaborate with multiple disciplines, including manufacturing, process engineering, process development, data scientists, utility operations, maintenance, quality assurance, and validation to implement operational improvements
• Author and execute test scripts or validation protocols
• Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues.
• Lead CAPAs and change controls, and work closely with the site MTS (Manufacturing technical services) team to implement changes
• Participate as a core team member on the NPI team to ensure all the automation changes/ MES changes are designed/tested as part of NPI readiness.
• Provide technical support to the manufacturing sites as needed, specific to process control and automation systems

Qualifications

• Required: B.S. or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
• Required: 4+ years relevant experience in pharmaceutical, biotech, or life sciences
• Required: Strong control system automation background.
• Required: Good understanding of design, installation, programming, and validation of automated processes.
• Required: Understanding of FDA CFR 21 Part 11 compliance
• Required: Established record of successful project completions employing proven engineering and project management skills
• Required: Demonstrated skills coding in DeltaV
• Required: Strong focus on quality and attention to detail
• Required: Motivated, self-starter with strong organizational skills
• Preferred: Experience in GMP environment, change control, and automation validation per GAMP5
• Preferred: Experience with Siemens, Allen-Bradley, Wonderware, or other automation platforms
• Preferred: Previous experience in computer software validation
• Preferred: Participation on global teams, Center of Excellence, etc.
• Preferred: Leverage GAMP5 risk-based approach when implementing changes to validated PAS
• Preferred: Authority inspection or audit support involvement
• Preferred: Experience with single-use technologies and systems
• Preferred: Experience with MES (Manufacturing Execution Systems)

Education

• B.S. or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.

Additional Requirements

• Occasional travel for global alignment.
• Flexible hours to accommodate collaboration with European teams.