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Role Summary
Senior Automation/Process Controls Engineer – Manufacturing Process Automation, Redmond site based. Part of the Automation team in Global MSAT responsible for defining DeltaV automation standards for the J.POD Manufacturing platform and providing automation support to manufacturing sites. Focused on designing and implementing solutions for a flexible, reconfigurable cGMP manufacturing facility with continuous processing, leveraging DeltaV and other automation platforms as needed.
Responsibilities
- Participate in design and implementation of automation and process control schemes for the JPOD continuous manufacturing platform, including batch tracking, process control limits, and predictive control.
- Maintain global validated DeltaV library and govern DeltaV platform change management to align across the manufacturing network.
- Define global software development life cycle (SDLC) and global roadmap for DeltaV.
- Engage with Site MSAT Automation teams to support global and site objectives.
- Collaborate with manufacturing, process engineering, process development, data science, utility operations, maintenance, QA, and validation for operational improvements.
- Author and execute test scripts or validation protocols.
- Lead or contribute to root cause analyses, incident investigations, and troubleshooting of process control issues.
- Provide technical support to manufacturing sites for process control and automation infrastructure.
- Provide project oversight or drive progress on PAS implementation projects with third-party suppliers/integrators with guidance from the team lead.
Qualifications
- Bachelor’s or Master’s degree in Engineering, Computer Science, or related field with 5+ years of relevant experience; or Associate’s degree with 8+ years; or High school diploma/GED with 10+ years.
- 2+ years in pharmaceutical, biotech, or life sciences industries in a GxP-regulated environment.
- Strong control system automation background; design, installation, programming, and validation of automated processes.
- Understanding of FDA CFR 21 Part 11 compliance.
- Proven track record of successful project completion with engineering and project management skills.
- Demonstrated skills coding in DeltaV.
- Motivated, self-starter with strong organizational skills.
Skills
- DeltaV process control automation (SCADA and DCS); familiarity with other platforms (Siemens, Allen-Bradley, Wonderware).
- GMP environment experience; change control and automation validation per GAMP5 guidelines (preferred).
Education
- As listed in Qualifications.
Additional Requirements
- Occasional travel to JEB Toulouse site (France) for global alignment.
- Flexible hours to collaborate with European teams.