
Engineer - Syncade or PharmaSuite MES System
- Indianapolis, IN
- $63,750-180,400 per year
- Permanent
- Full-time
- Develop and integrate MES common and site-specific components.
- Develops and/or assists in the creation and maintenance of the MES interfaces with other Lilly systems.
- Evaluate and translate functional requirements into technical solutions.
- Support MES solutions start up activities.
- Work with site resources towards replication & standardization to drive value and implement the appropriate technical solutions.
- Ensure project and/or validation documentation is maintained during lifecycle & release management.
- Evaluate new technologies and implications to existing Lilly footprint.
- Benchmark on innovative solutions (external and internal to Lilly)
- Maintain open communication with MES vendor(s) to address needs in standard solution or via functional packs.
- Dynamically adapt roadmap to site evolution/strategic directions, and new trends/issues.
- Establish a strong site culture based in Lilly values, expectations, and operational excellence standards.
- Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)
- Effective people and team leadership skills
- Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities.
- Ability to cross functionally collaborate.
- Excellent written and oral communication skills.
- Demonstrate creativity, analytical thinking, and the ability to troubleshoot and tackle problems.
- History of promoting safety and maintaining a safe work environment
- Demonstrated adhere adherence to compliance for internal and external quality guidance.
- Demonstrated and promote Operational Excellence
- Effectively encourage knowledge sharing and education
- Ability to problem solving and work through manufacturing situations. Have experience serving as an escalation contact with vendor(s)
- Bachelor’s degree in engineering, Computer Science, Information Technology, or a related technical field.
- Minimum 2 years of experience working with Manufacturing Execution Systems (MES), with in the pharmaceutical or life sciences industry.
- 2+ years technical ability to develop and integrate MES solutions.
- Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred.
- Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11).
- Experience authoring and validating Master Batch Records (MBRs) in a regulated environment.
- Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
- Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders.
- Proficiency in English (written and spoken).
- Position locations: Indianapolis [ US, PR sites]
- Occasional off-hours and weekend work expected.
- 10-15% domestic/international travel required. [ Local 10-15%, Global 15-30%]