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Engineer - Process

Eli Lilly and Company

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Location: Indianapolis, IN Posted Date: 4/22/2013 Position Type: Full time Job Code: 1752BR Required Education: Bachelors Degree Areas of Expertise Desired: Engineering
Manufacturing/Production

Description

Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity:

Responsibilities:
The Cartridge Project in Indianapolis Parenteral Operations will deliver a high speed cartridge manufacturing facility to provide cartridge manufacturing capacity for the Parenteral Network. The position will initially be as a member of the Parenteral Cartridge project team, providing technical & engineering leadership and knowledge for the design of the area, specifying, purchasing, delivering, and qualifying equipment and processes associated with the formulation and filling of insulin cartridges. As the equipment is qualified, the position will transition to an engineering floor support role, providing direct technical support to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures.

Key Objectives/Deliverables:
•   Provide technical and project management leadership and capability to the cartridge team in the design, delivery, and qualification of the area, equipment, and processes associated with the formulation and filling of cartridges. Coordinate all site work with the global cartridge team for the design and delivery of the facility, primary and support equipment.
•   Understand the engineering requirements for manufacturing parenteral drug products (focus on insulin cartridges), and ensure they are integrated into the design and project.
•   Ensure safety is built into the equipment and processes and help monitor and develop a strong safety culture.
•   Prepare, review, approve, and provide technical support for preparation and execution of relevant technical documents.
•   Ensure that systems are set up to maintain and efficiently operate the formulation and preparation processes including PMs, Spare Parts, Technical Drawings / Manuals, technical training, metrics collection, etc.
•   Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
•   Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross-functional teams in positive fashion to implement process team objectives and deliver on business plan and quality objectives.

Requirements

Basic Qualifications:
•   Bachelor’s degree in Engineering or equivalent technical degree.
•   Demonstrated ability in organizing and leading technical projects including working with equipment suppliers.
•   Knowledge of piping and / or skid systems.
•   Good written and oral communications, including demonstrated ability creating and reviewing technical documents.
•   Strong interpersonal and communication skills to be effective in a team based situation.
•   Demonstrated ability to solve difficult technical problems and implement solutions
•   Teamwork and interpersonal skills
•   Computer skills
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 or TN status) for this employment position

Additional Preferences:
•   Knowledge of container closure systems, component processing equipment, washers, autoclaves, and formulation systems, and /or pharmaceutical filling systems
•   Knowledge of automation platforms
•   Ability to work across functional, geographic, external boundaries
•   Foundational knowledge of project management
•   Experience working on a process team or project team delivering a capital project.
•   Experience working with formulation and filling of parenteral products, insulin or cartridges.
•   Experience researching and replicating the work of other areas / facilities
•   Experience working hands on with equipment and processes and to train other technical staff and operators.
•   Experience applying cGMPs.

Additional Information:
•   Position will require frequent travel early on for the design and delivery of the new area.
•   Could be as much as 25% in 2013, and 2014. Will likely taper down significantly in the following years.
•   Position is a day shift role, but requires flexibility to adjust schedule as needed to support the installation, qualification, and ongoing running of the area (24/7 operation)
•   Required to carry a phone or pager to support design, start up and ongoing operations.
•   Required Safety Equipment: Safety glasses, gowning, hearing protection, and safety shoes required per local area requirements.
•   Product Exposure: Position will work with various Lilly products (Mostly Insulin) Position requires person to be willing and able to be qualified to gown in all areas associated with the process in order to support the qualification and ongoing operations.

ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
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