Engineer- Automation

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Engineer – Automation will develop, implement, and continuously improve process automation solutions within Indianapolis Device Assembly and Packaging (IDAP) to ensure that business goals are achieved for the Process Team they support.  This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment specific code and/or control system technologies.

The Engineer–Automation is responsible for equipment performance, providing first–line support to production processes, and supporting area engineering initiatives, process improvements, and small project implementation.  This will be done while ensuring that process automation solutions / systems are in-control, capable, and compliant.

Key Objectives / Deliverables:

Safety

Ensure a safe working environment by enforcing and following HSE policies and ergonomic environment within process team.

Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.

Wear proper personal protective equipment (gloves, steel-toed shoes, safety glasses) as required by local procedures and the activity being performed.

Understand safe operation of the equipment within the area.

Quality and Reliability

Line Support:

Serve as first tier support for automation system users:

Lead and/or participate in troubleshooting downtime events in collaboration with process engineers, engineering technicians, maintenance, and operations.

Leverage control system and electrical data to support troubleshooting, provide solutions and implement actions.

Understand the production process procedures and critical process parameters.

Understand customer needs and issues associated with new and existing process control systems.

Proactively evaluate automation code to identify and correct code opportunities.

Perform activities in accordance with cGMPs and applicable procedures.

Assist and/or lead deviation(s) investigation(s).  Evaluate events proactively to avoid interventions and near misses.

Project Implementation:

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.

If applicable, serve as Serialization Technical Process Facilitator (TPF) attending meetings (monthly logistics update, technical team(s) for Serialization Execution System (SES) updates, etc.) as well as local Subject Matter Expert (SME) for SES.

Support site facilities startup and qualification activities (e.g., commissioning, C&Q activities, etc.) from the automation perspective.

Develop and maintain validation documentation.

Lead or manage small projects or initiatives related to automation technologies.

Develop implementation schedule.

Select and/or oversee contractors and/or technicians for the fulfillment of these projects.

Provide technical guidance to contractors.

Coordinate project activities with site personnel.

Monitor progress and communicate status.

Identify roadblocks and provide alternatives to deliver projects on time and within budget.

Technical Contributions:

Support site facilities startup and qualification activities (e.g., commissioning, C&Q activities, etc.) from the automation perspective.

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.

Understand customer needs and issues associated with new and existing process control systems.

Monitor, analyze, and define action plans to for continuous improvements activities on the lines they support.

Perform analysis to identify trends.  Understand data trends of assigned area and proactively get involved and/or support discussion(s) and action plans.

Monitor compliance of AQMS (Asset Qualification Monitoring Strategy), automation change strategy and ensure compliance with all requirements, policies, and regulations.

Proactively evaluate automation code to identify and correct code opportunities to avoid product losses or overall performance of the line.

Assist and/or lead deviation(s) investigation(s). Evaluate events proactively to avoid interventions and near misses.

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).

If applicable, serve as Serialization Technical Process Facilitator (TPF) attending meetings (monthly logistics update, technical team(s) for Serialization Execution System (SES) updates, etc.) as well as local Subject Matter Expert (SME) for SES.

Stay tightly aligned and actively involved with internal customers. Understand their issues, priorities, and objectives.  Respond to and implement customer requests.

Define user requirements, system architectures, and code.

Deliver projects on time and within cost constraints.

Manage contract resources while maintaining ownership for the end product.

Copy, reuse and replicate standards and control code developed by others.

Stay current with validation expectations.

Develop and maintain validation documentation.

Develop and implement methods or procedures that build a consistent validation infrastructure and ensure that IT / Automation related activities can be executed, as written, so that practice matches procedure.  Seek ways to improve practices that will have impact across multiple projects.

Manage instrumentation assets through the life cycle.

Have a basic understanding of Infrastructure / Telecom.

Own and manage the systems administration:  User management, patches / fixes, and Firmware Updates.

Broad Technical Knowledge

General understanding of the PFD’s, CPPs (Critical Process Parameter), and the SFDs of area of support and how they are affected.

General understanding of area control strategy and monitoring critical operational parameters of the assigned area including trend analysis. (Q & EHS, Productivity, etc.)

General understanding of Data Flow, S95, MES (Manufacturing Execution System), SAP, and its integration with our controls systems.

General knowledge in multiple technologies such as Vision, PLC (Programmable Logic Controller), VFD (Variable Frequency Drives), etc.

General knowledge in MES structure and configuration.

Comprehensive knowledge of the code and process of several process steps or buildings, plant operations and other support areas.

Understand where to look for information and data. Makes technical recommendations for process control improvements, applies first Principles and influence in process teams for implementing improvements.

Develop technical documentation to capture and share knowledge.

Knowledge Sharing, Mentoring, & Collaboration:

Participate in teams designated by supervision.

Attend and proactively participate in team meetings and huddle board discussions.

Contribute to team performance action plans.

Maintain process team or area informed of activities and status, as applicable.

Identify all roadblocks and communicate to the appropriate level on time.

Represent the Automation area by sharing priorities, strategies, schedules, and project updates to team members.

Be influential and vocal in the teams.

Understand and follow internal and external Computer Systems Quality policies, procedures, and regulations that apply to the automation systems they support.

Keep current on training required for Lilly computer systems quality policies and procedures.

Follow all local and global policies and procedure to maintain validated state of our control systems.

Communicate to supervision any non-conformance or risk that could affect the validated state of our control systems or processes.

Comply with Good Manufacturing Practices and Good Documentation Practices.

Always maintain an inspection readiness mindset.

Requirements:

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

Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.

Ability to work safely to ensure the safety of self and others.

Have a basic understanding of Infrastructure / Telecom.

Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE (Health Safety and Environment) Corporate and Site Goals.

Additional Preferences:

Previous experience as a process automation engineer or process engineer is desirable.

Pharmaceutical experience is desirable.

Computer System Validation experience is desirable.

Code base preferences: Rockwell, Cognex, Systech, ELAU

Hands-on experience with PLC (Programmable Logic Controller) programming and troubleshooting.

Familiarity with industrial communication protocols such as Modbus, OPC, and Ethernet/IP.

Other Information:

8-hour days, after-hour support.

  Occasional travel may be required for training, conferences, capital projects, etc.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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