Sr Automation Engineer III

仕事内容

Essential Duties and Job Functions:

We are seeking a highly skilled Senior Automation Engineer to support Biologics technical development, clinical, and manufacturing facilities.

Key Responsibilities

• Lead the design, development, deployment, and lifecycle management of automation solutions using Emerson DeltaV DCS, with emphasis on batch control (S88), recipe management, and phase logic execution.
• Support PI Historian system for real-time and historical data collection, trending, Asset Framework creation, and analysis for process monitoring and continuous improvement.
• Integrate biologics laboratory, pilot, clinical, and manufacturing equipment/systems via APIs, OPC UA, and other protocols to ensure seamless data flow across R&D, clinical, and GMP environments.
• Support integration of DCS / Historian with MES platforms.
• Implement and manage automation changes in GMP environments, including hardware/software upgrades, vendor coordination, change control, and qualification/validation activities.
• Manage external contractors and third-party integrators, including scope definition, performance monitoring, deliverable review, and budget/schedule oversight.
• Provide technical mentorship and guidance to junior automation engineers.
• Collaborate with cross-functional teams (Technical Development, Manufacturing, QA, QC, IT) to deliver automation projects that meet cost, quality, timeline, and regulatory goals.
• Maintain comprehensive, compliant automation documentation (URS, FS, DS, SOPs, risk assessments, validation protocols).
• Lead validation and qualification efforts in collaboration with QA to ensure adherence to GAMP 5, 21 CFR Part 11, and Annex 11 requirements.

Required Knowledge, Experience, and Skills

• Extensive hands-on experience with Emerson DeltaV DCS, including configuration of batch control, control/equipment modules, and phase logic.
• Proficiency in industrial protocols (OPC UA, Modbus, Ethernet/IP).
• Strong expertise in Aveva PI System (PI Adapters/interfaces, PI Data Archive, PI AF, PI Vision).
• Experience integrating DCS or Historian with MES (e.g., Apprentice Tempo MES or Werum PAS-X).
• Proven background in GMP automation within biologics, cell/gene therapy, or large-molecule manufacturing.
• Demonstrated experience managing contractors and system integrators.
• Track record of mentoring junior engineers and fostering a collaborative team environment.
• Ability to rapidly learn and adopt new automation platforms, Cloud Services, and DevOps tools (e.g., Ignition SCADA, MQTT/Sparkplug, GitHub).
• Strong troubleshooting and problem-solving skills; structured approach to root-cause analysis.
• Excellent communication and stakeholder management skills; ability to present complex concepts to technical and non-technical audiences.
• Must be able to work onsite at least 3 days per week.

Basic Qualifications

• BS in Computer Science, Electrical, Chemical, or Mechanical Engineering from an accredited university with at least 10 years of relevant automation engineering experience in life sciences.

OR

• MS in Computer Science, Electrical, Chemical, or Mechanical Engineering from an accredited university with at least 8 years of relevant automation engineering experience in life sciences.

Preferred Qualifications

• Proficiency in PLC (Rockwell, Siemens, Opto22) and SCADA platforms (Ignition).
• Programming experience in Python or .NET for automation scripting and API integration.
• Experience with AWS cloud services (EC2, S3, Lambda, RDS, IoT Core) and DevOps tools (Git, CI/CD pipelines, Terraform, Ansible).