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 pen injector medical devices. The Sr Specialist- Automation is responsible for equipment performance, providing a first line support to production processes, as well as supporting area engineering initiatives, process improvements, and project implementation. 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 Sr Specialist- Automation will help ensure that equipment is maintained in a qualified state, can be operated safely, and maintenance is properly performed on the systems (performing maintenance activities on equipment is not in the scope of this position).
Safety: Assure that operational and maintenance procedures and practices reflect safety concerns. Find and eliminate safety issues with the equipment and processes. Participate on safety reviews and audits, as required. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Quality: Perform activities in accordance with cGMPs and applicable procedures. Understand the production process and critical process parameters. Understand equipment specific code and control systems that maintain a qualified/validated process. Understand the code development, modification and deployment processes as they relate to cGMP processes. Identify opportunities to improve quality using equipment performance data and by assuring maintenance is performed appropriately.
Manufacturing Support: Working with the process team, including engineers and operations personnel, participate in and sometimes lead development of equipment design, procedures, studies, and maintenance practices that will enable the process to operate as required. Seek out and identify opportunities to improve equipment operational effectiveness and reliability. Provide technical support for process and engineering teams. Monitor specific plant data for out of control signals and begin investigations into causes. Attend and participate in team meetings.
Provide technical support to engineering: Investigating and resolving issues that create production delays. Transferring knowledge of equipment capabilities and operational techniques to operators, engineering, and maintenance. Implementing tools for operations and engineering to learn and work more proficiently. Contractor and vendor coordination. Participate in periodic reviews of equipment state. Plan and execute small projects for process or equipment improvements or changes.
Key Minimum Requirements:
- High School education or GED
- Experience in a GMP manufacturing environment
- Experience in instrumentation, PLC and/or HMI programming
- Demonstrated ability to work safely in a participative environment
- Strong equipment/process troubleshooting skills
- Demonstrated proficiency with Microsoft Word and Excel; proficient at typing and writing technical documents.
- Demonstrated ability to work independently with strong organizational skills and attention to detail and ability to adapt to rapidly changing priorities
- Demonstrated strong interpersonal skills and communications skills with a customer service attitude
- Experience with Maximo or similar computerized maintenance management system
- Experience with control system platforms, such as Systech, Cognex, Rockwell, Siemens, Elau, TrakSys, FTMetrics, Windows
- Associates Degree or equivalent work experience preferred
- 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.
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:
- Flexibility to off-hours when needed in support of a 24/7 operation Knowledge of Parenteral equipment and manufacturing operations
- 8 hour days Monday through Friday overtime will be required
- Required to wear pager/cell phone off shift and respond to operational issues.
- Minimal travel required
- Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
- Post offer exam required for this position
Awards and Recognition
LILLY IS AN EQUAL OPPORTUNITY EMPLOYER
Eli Lilly - 12 months ago
Eli Lilly and Company discovers, develops, manufactures and sells products in one business segment, pharmaceutical products. The Company als...