Senior Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday - Friday

Senior Manufacturing Systems Engineer:
Automation - DeltaV Live

In this critical role, you will provide automation technical leadership to a team of engineers who build and maintain automation systems that support GMP Drug Substance Plant Operations. You will work closely with the capital project team to deliver robust process automation for the new plant.

Schedule:

Swing Shift 3pm – 11pm, Monday through Friday.

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Collaborate with process subject matter experts to translate key process requirements into digital automated solutions.
• Work with business partners to identify workflow and productivity improvements through automation.
• Create documentation for delivered solutions and processes; support QA partners during computerized systems validation in a GxP environment.
• Maintain data integrity assessments in line with Amgen and industry standards.
• Develop business processes aligned with project timelines and scope.
• Write detailed specifications, engineering policies, and procedures affecting multiple organizational units.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Own and drive completion of change controls, CAPAs, and deviations.
• Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
• Support new product introduction (NPI) or new technology introductions by performing automation assessments and implementing configuration changes.
• Oversee day‑to‑day operational support: 24×7 onsite/on‑call support, troubleshooting, preventive and corrective maintenance, system administration, spare parts management.
• Prepare and review standard operating procedures (SOP) and cGMP documents.

• High school diploma or GED with 10+ years of engineering experience; associate’s degree with 8+ years; bachelor’s degree with 4+ years; master’s degree with 2+ years; doctorate preferred.
• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of automation system design, experience in process control engineering and troubleshooting in GMP biopharmaceutical facilities.
• Extensive background in programming, design, installation, and lifecycle management of manufacturing process controls and automation.
• Experience with Emerson DeltaV DCS, process control network design, and integration technologies (OPC, Foundation Fieldbus, Profibus, Device Net);
  DeltaV Live preferred.
• Ability to apply GAMP and GMP standards, including 21 CFR Part 11, ASTM 2500, S88, and S95.
• Experience with capital project lifecycle management: concept, scope, cost estimates, business case, design, validation documentation, and execution.
• Hands‑on experience developing process control strategies for NPI and technology deployment.
• Track record of continuous improvements enhancing safety, reliability, and productivity.
• Self‑directed team player capable of mentoring staff and collaborating in a team‑based culture.
• Strong leadership, technical writing, and communication/presentation skills.

• Comprehensive employee benefits package: health, dental, vision, life and disability insurance, flexible spending accounts.
• Retirement and savings plan with generous company contributions.
• Discretionary annual bonus program.
• Stock‑based long‑term incentives.
• Time‑off plans and bi‑annual company shutdowns.
• Flexible work models, including remote work arrangements where possible.

USD  –  per year.