Lead Process Engineer - Vial Packaging - Eli Lilly and Company

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.

Position Brand Description:

This position is in the Indianapolis Device Assembly and Packaging site.  The mission of IDAP and Manufacturing at Lilly is to make medicine with safety first and quality always.

The Lead Process Engineer is the equipment expert for all processes supported by the cross functional business area they are assigned.  The Lead Process Engineer is responsible for ensuring all equipment in their process area is reliable, remains in a qualified state, and is capable of meeting customer needs while also driving associated continuous improvement effort.  The Lead Engineer serves as coach and mentor to Process and Automation engineers on their process team.  This is done by transferring knowledge, supporting when escalated to and by prioritizing and leading projects.

Safety

• Ensure a safe working environment by enforcing, educating others, 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.
• Take responsibility for the safe design and safe operation of the equipment within the area.

Quality and Reliability

• Obtain technical expertise of equipment and processes in area of responsibility.
• Maintain the equipment flow chart / process flow document, critical process parameters, and Control Strategy for responsible process areas.
• Coach and support process and automation engineers through troubleshooting efforts to resolve equipment and operational problems.
• Lead troubleshooting efforts to resolve major equipment and operational problems, particularly problems applicable to multiplate processes or equipment lines.  Apply formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues.
• Analyze and monitor / trend equipment process and controls as tool for verifying and optimizing equipment performance.
• Participate in cross functional data-based discussions about equipment performance to identify and prioritize improvement initiatives that are aligned with process area business needs (bottleneck analysis, special and common cause downtime elimination, batch to batch startup resolutions).

Safety

• Ensure a safe working environment by enforcing, educating others, 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.
• Take responsibility for the safe design and safe operation of the equipment within the area.

Quality and Reliability

• Obtain technical expertise of equipment and processes in area of responsibility.
• Maintain the equipment flow chart / process flow document, critical process parameters, and Control Strategy for responsible process areas.
• Coach and support process and automation engineers through troubleshooting efforts to resolve equipment and operational problems.
• Lead troubleshooting efforts to resolve major equipment and operational problems, particularly problems applicable to multiplate processes or equipment lines.  Apply formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues.
• Analyze and monitor / trend equipment process and controls as tool for verifying and optimizing equipment performance.
• Participate in cross functional data-based discussions about equipment performance to identify and prioritize improvement initiatives that are aligned with process area business needs (bottleneck analysis, special and common cause downtime elimination, batch to batch startup resolutions).
• Lead equipment related deviation investigations, identify potential equipment failure modes, and coordinate the implementation of appropriate countermeasure for equipment related deviations.
• Coach others on how to maintain the qualified state of the equipment through asset life cycle changes, maintenance work, and interventions.
• Create and ensure equipment related procedures and instructions can be executed as written so that practice matches procedure.
• Support the implementation of and define the scope of changes required due to commercialization modifications and additions in applicable process area.
• Evaluate all engineering activities in process area for impact on the qualified state of the equipment and ensure appropriate methods are leveraged to document changes, maintenance work, and interventions (Change Controls, Work Orders, Service Tickets).
• Lead and participate in IQ / OQ / PQ activities on process equipment.
• Act as user representative for capital initiatives in assigned process team and any other process area based on business needs.
• Lead cross functional teams to define and improve the maintenance strategy for process area.
• Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within process area.
• Coordinate and collaborate with resources (sites, vendors, process team) to identify opportunities and replicate improvements across the manufacturing network.

Fundamental Deliverables

• Communicate effectively with others, especially process team members, customers, engineering techs, and crafts personnel.
• Educate, coach, and collaborate with process team members focusing on Process and Automation Engineers.
• Be prepared for and participate in process team meetings.
• Use project management practices for improvement initiatives and communicate the status of initiatives to process team.
• Prioritize time and task execution based on impact to business needs.
• Escalate technical, safety, and quality issues as recommended by process area.
• Serve as representative and maintain relationships with other business units, (IDM, Global Packaging, Global Robotics), manufacturing sites, and external vendors.
• Maintain completion of all required learning for job responsibilities.

Minimum Requirements:

• Bachelor’s Degree and 2+ years experience or;
• Associates Degree and  7+ years experience or;
• High School Diploma and 10+ years experience
• Strong interpersonal and communications skills to be able to work effectively in a team-based environment.
• Effective mentoring and coaching ability to share technical knowledge.
• Strong computer skills in a variety of software packages (Excel, PowerBi, etc.).
• Ability to work in a safe manner to ensure the safety of self and others.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Preferences:

• Previous experience as a process engineer
• Previous experience in the Pharmaceutical Industry
• Previous experience in project management

Other Information:

• 8 hour days, after-hour and weekend support as needed
• Occasional travel may be required for training, conferences, capital projects, etc.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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