Senior Automation Engineer

Role Summary

The Senior Automation Engineer will own automation-related tasks, projects, and support for GMP manufacturing systems. Core responsibilities include automation and I&C maintenance and troubleshooting, owning and supporting automation-related projects on GMP equipment, including installation, startup, commissioning, testing and qualification of automated systems at Wave’s Lexington Manufacturing site. The role contributes to the design and implementation of new control systems during facility expansions and equipment upgrades, and requires the ability to work independently and collaboratively across functional areas to enable the manufacturing of Wave’s investigational products.

Responsibilities

• Maintain and improve automation systems, instrumentation, and controls used on GMP equipment and to monitor manufacturing operations
• Lead automation and I&C-related troubleshooting activities in partnership with internal subject matter experts and equipment vendors
• Develop processes to improve GMP equipment automation and I&C reliability
• Develop and maintain Engineering Specifications (URS, FRS, DDS, HDS, SDS), drawings, SOPs, and preventative maintenance plans
• Manage projects focused on the modification of existing cGMP control systems and infrastructure (on equipment and stand-alone systems)
• Provide automation support to aid the design and implementation of new GMP equipment
• Author, review, and execute commissioning/validation protocols and engineering test plans
• Own quality events related to equipment automation and systems
• Train internal teams on automated systems and automation best practices
• Work primarily onsite at Wave’s Lexington facility

Qualifications

• Required: Degree in Engineering discipline or equivalent
• Required: 3-5 years of demonstrated experience in industrial automation, instrumentation, and controls applied in support of cGMP manufacturing operations, equipment, and/or facilities
• Required: Experience managing/supporting engineering and capital projects

Skills

• Experience with automation systems such as Allen Bradley or Siemens PLC platforms, Delta V DCS platform, Schneider Electric or Johnson Controls BMS platforms, iFix, Factory Talk, ignition SCADA systems, data systems (PI, IP21, Crystal Reports, etc.) and data integration solutions (OPC, Kepware, Matrikon, LabX, Web API, etc.)
• SQL databases experience (e.g. backups, restoration, relocation)
• Knowledgeable in VMware/Hypervisor environment
• Experience in Programmable Logic Controller or Distributive Control System programming, and Data Historian and Report Configuration
• Proficient understanding of instrumentation, and its configuration, Industrial Control networking such as Ethernet IP, Profibus, or AS-I networks
• Demonstrated experience of Windows OS, Networking & System Security Fundamentals
• Experience with ISA-S88, ISA-S95, and ASTM 2500 principles
• Familiarity with 21 CFR Part 11 and data integrity
• Ability to climb ladders and work in tight spaces with equipment (bending, squatting, twisting)
• Able to lift objects of 25-50 pounds, push/pull objects, apply firm grasp and/or reach above shoulder height, and gown in/out of cleanroom areas
• Must be able to use personal cell phone for emergency team, as necessary

Education

• Degree in Engineering discipline or equivalent