Engineer - Syncade or PharmaSuite MES System

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.

Lilly’s Purpose 

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to build new state-of-the-art manufacturing site’s and continue growing our existing facilities to created capacity required to continue with our mission. The brand-new facilities will apply the newest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

What You’ll Be Doing:

We are on a daring journey to transform our manufacturing operations, and the Manufacturing Execution System (MES) is pivotal to achieving this transformation. Multiple projects are currently underway to expand the footprint of MES, enabling new facilities to operate paperless and modernizing MES in established operations worldwide.

The MES System Engineer will ensure the successful implementation of the MES solutions by bridging business needs and technology. This role will develop expertise in PharmaSuite OR Syncade supporting, developing and validating global electronic batch records to fulfil business needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges.

Key Responsibilities:

• 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.

What You Should Bring (preferred skills:

• 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)

Basic Requirements:

• 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.

Additional Preferences

• 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).

Additional Information:

• 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%]

#WeAreLilly

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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly