Engineer - Process Automation / IDAP Site Expansion - Assembly

Role Summary

Role: Engineer – Process Automation, part of the IDAP Expansion Team, responsible for the automation systems, controls and integration of assigned equipment. The role is the area expert for automation aspects of asset delivery within IDAP, partnering with asset delivery SMEs, IDAP Site automation and infrastructure to ensure the equipment is delivered, qualified and capable of meeting customer needs. The Engineer will support the ramp up and handover to the process team after defined milestones. Location: Indianapolis, Indiana.

Responsibilities

• Safety Ensure a safe working environment by enforcing and following HSE policies and ergonomic practices within the process team.
• Safety Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.
• Safety Wear proper personal protective equipment (gloves, steel-toed shoes, safety glasses) as required by local procedures and the activity being performed.
• Safety Understand safe operation of the equipment within the area.
• Asset Delivery Obtain technical expertise of equipment and processes in area of responsibility.
  • Have a basic understanding of Infrastructure / Telecom.
  • General understanding of Data Flow, S95, MES (Manufacturing Execution System), SAP, and its integration with our controls systems.
  • Knowledgeable in multiple technologies such as Vision, PLC, VFDs, etc.
  • Knowledgeable in Data Integrity requirements and expectations, ensuring appropriate integration into assets within scope
  • Comprehensive knowledge of the code and process for assets assigned
• Develop a deep understanding of Global and local requirements and expectations for Asset delivery
• Understand equipment flow chart / process flow document, critical process parameters, and Control Strategy for responsible process area.
• Understand design and user requirements of equipment and fundamental understanding of the operational area’s processes where the asset will reside
• Understand customer needs and issues associated with new and existing process control systems.
• Actively participate in project meetings, connect with delivery organizations and OEM and engage in the overall C&Q process throughout project, preparing asset for PV
• Work with the project team to ensure that design, code development, and testing approaches are in line with agreed standards.
• Leverage control system and electrical data to support troubleshooting, provide solutions and implement actions.
• Perform activities in accordance with cGMPs and applicable procedures.
• Proactively evaluate automation code to identify and correct code opportunities.
• Ramp Up Phase
  • Monitor, analyze, and trend data to define action plans for data integrity, process efficiency, and commercialization continuous improvements.
  • Monitor and enforce compliance of AQMS (Asset Qualification Monitoring Strategy), automation change strategy, and ensure compliance with all requirements, policies, and regulations.
  • Lead or manage small projects or initiatives related to automation technologies.
  • Continuously monitor and perform assessments in the assigned area of support to proactively identify opportunities and implement corrections to deliver results, drive productivity, and to be more agile and competitive
  • Support equipment related deviation investigations, understand potential equipment failure modes, and implement appropriate countermeasure for equipment related deviations.
  • Initiate change controls to optimize the systems or processes, including business case, technical recommendations, and resources / cost estimates.
  • Implement and/or support implementation of the change controls (complete all information, follow up approval signatures, close the document).
  • Participate as a Process Team member as technical SME and train individuals as appropriate to assume process automation engineering responsibilities
• Fundamental Deliverables
  • Communicate effectively with others, especially project/process team members, customers, engineering techs, and crafts personnel.
  • Educate, coach, and collaborate with process team members including Operations, Maintenance, and Engineering front line staff.
  • Be prepared for and participate in project team meetings
  • Identify roadblocks and communicate to the appropriate level on time.
  • Use project management practices for meeting project commitments and communicate the status of initiatives to project team.
  • Prioritize time and task execution based on impact to business needs.
  • Escalate technical, safety, and quality issues as recommended by process area.

Qualifications

• Required: Experience supporting GMP production
• Required: Authorized to work in the United States on a full-time basis

Skills

• Knowledgeable in multiple technologies such as Vision, PLC, VFDs
• General understanding of Data Flow, S95, MES, SAP, and integration with controls systems
• Knowledgeable in Data Integrity requirements and expectations
• Comprehensive knowledge of the code and process for assets assigned
• Strong interpersonal and communications skills to work effectively in a team-based environment
• Have a basic understanding of Infrastructure / Telecom
• Familiarity with cGMPs and related procedures

Education

• Bachelor's Degree in Engineering (or equivalent work experience)

Additional Requirements

• 8-hour days, after-hour support.
• Extended travel / stays may be required to support / learn from other site start-ups for similar equipment
• Travel to US and OUS (4-12 weeks/yr) will be required for OEM interactions, FAT testing, and other project requirements