Syncade or PharmaSuite MES System Engineer

Eli Lilly and Company; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical firm is seeking an MES System Engineer in Indianapolis. This role will bridge business needs and technology, ensuring compliance and developing global electronic batch records. The ideal candidate will have a Bachelor's degree, 2+ years' experience with MES, and knowledge of regulatory compliance. Excellent communication skills and problem-solving abilities are essential for success in this role. Occasional travel is required.

Qualifications

• Minimum 2 years of experience working with Manufacturing Execution Systems (MES).
• Experience with GMP regulations and Computer System Validation (CSV) principles.
• Strong documentation skills with experience in generating validation deliverables.

Responsibilities

• Develop and integrate MES common and site-specific components.
• Ensure compliance with validation requirements.
• Work with site resources towards replication & standardization.

Skills

Pharmaceutical Manufacturing Regulatory compliance knowledge

Effective people and team leadership skills

Ability to manage multiple concurrent activities

Excellent written and oral communication skills

Demonstrated creativity and analytical thinking

History of promoting safety

Problem-solving ability

Education

Bachelor’s degree in engineering or related field

Tools

PharmaSuite

Syncade

PMX

Werum PAS-X

Job description

Overview

Syncade or PharmaSuite MES System Engineer at Eli Lilly and Company. The MES System Engineer will ensure the successful implementation of 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

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