Process Engineer

Job Description
Job Description

For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a Best in Class Pharmaceutical company, please review the following opportunity:

Process Engineer

Parental Device Assembly and Packaging (PDAP), a part of Indianapolis Parenteral Manufacturing (IPM), leverages production lines for two types of finishing operations: 1) labeling and packaging of parenteral products (from DC & DHC) 2) assembly, labeling and packaging of peninjector medical devices. The Process Engineer role is designed tor espond to daily equipment issues, determine the root cause of equipment related events and implement process improvements.



KEY OBJECTIVES/DELIVERABLES:


Safety


Monitor and build strong safety culture.

Identify hazards and support countermeasure implementation.

Utilize safety systems such as LOTO, live equipment troubleshooting, and safe work permit policies when appropriate.


Quality


Ensures compliance of corporate CSV (Computer System Validation) policies and procedures that apply to Parenteral Device Assembly and Packaging (PDAP) Operations.

Coordinates system backup/restore and security Leads or participates in IQ/OQ/PQ activities (including commissioning activities of new or modified equipment).

Supports periodic reviews (PRs) for equipment and automation systems.

Identifies and implements solutions for compliance improvements.


Technical Leadership


Serves as system custodian for automation hardware and software.

Uses statistical thinking and methods to understand process variability and capability and drive improvements.

Drives improvement of nuisance alarms and alarm response.

Determines process capacities and bottlenecks, implements improvements, and develops contingency plans for capacity/productivity increases.

Assesses and implements improvements in productivity, waste generation, quality and cost of manufacture as part of process team.

Develops and applies understanding of cause and effect relationships within the assembly process.

Assists with the development of necessary documentation to describe machine operation and machine maintenance.

Facilitate technology transfer/exchange with associated device manufacturing operations and OEM's.

Develops and monitors key equipment performance metrics such as equipment down time and reject trends.

Assist with the development of the necessary documentation to describe machine operation and machine maintenance.


Manufacturing Support


Leads or participates in problem solving activities including root cause analysis and countermeasure development and implementation utilizing the Trackwise system.

Acts as resource for development and implementation of procedures and training.

Support any improvements made to equipment, processes or procedures, where changes to PLC programs or other controls are involved.

Resource for troubleshooting equipment with operations and maintenance.

Interacts with automation personnel to address issues or implement improvements.

Uses 6 sigma tools to identify areas for improvement and implements those improvements.


Asset Management/Reliability


Maintains accurate asset information including CMMS data, equipment drawings, specs, FMEA's, etc.

Ensures automation documentation is accurate and complete.

Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure.

Assist with identification of spare parts for equipment and computer hardware.

Assist with the development of preventive maintenance procedures for the pen assembly equipment and automation infrastructure.

Stay current on existing technology by meeting with vendors and manufacturers in order to evaluate new products and procedures, which may help to improve PDAP production currently or in the future.


MINIMUM REQUIREMENTS:


Bachelors Degree.

Experience in a GMP production environment.

Experience with Packaging or Device assembly equipment or similar processing equipment.

Ability to organize and prioritize multiple tasks.

Ability to effectively communicate with all stakeholders (Operations, Maintenance, Engineering, Quality, etc.).

Ability to work independently.

Decision-making skills and ability to exert good judgment.

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B status) for this employment position.

Flexibility to off-hours when needed in support of a 24/7 operation.


ADDITIONAL PREFERENCES:


Trackwise Lead Investigator and change owner experience

Software Experience: Factory Talk View SE, RSLogix 5000, RSLogix 500, RSLogix5, ControlLogix, SLC500, PLC-5, Siemens SL7.


OTHER CONSIDERATIONS:


PPE must be worn in production areas.

Less than 5% Travel.

Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.

Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community. The following is a selection of awards and recognition Lilly has received in recent years:
Awards and Recognition


ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER

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Company

Eli Lilly

Job Code

State or Province

Indiana

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