Engineer - Syncade or PharmaSuite MES System

BioSpace; Indianapolis (IN); On-site; USD 63,750 - 180,400; Full time

Benefits offered by this job

Competitive salary

Company bonus

Comprehensive benefits

Job summary

A leading healthcare company in Indianapolis is seeking an Engineer for the Syncade and PharmaSuite MES System. The role focuses on developing and implementing manufacturing execution systems, ensuring compliance, and collaborating with global teams. Ideal candidates will have a bachelor's degree in engineering and at least 2 years of relevant experience in the pharmaceutical industry. This position offers a competitive salary, potential bonuses, and comprehensive benefits.

Qualifications

• Minimum 2 years of experience with Manufacturing Execution Systems (MES) in the pharmaceutical or life sciences industry.
• Experience developing and integrating MES solutions.
• Understanding of GMP regulations and Computer System Validation principles.

Responsibilities

• Develop and integrate MES components.
• Support MES solutions startup activities.
• Ensure compliance with validation requirements.
• Work closely with global teams.

Skills

Pharmaceutical Manufacturing Regulatory compliance knowledge

Effective people and team leadership skills

Excellent written and oral communication skills

Ability to manage multiple concurrent activities

Ability to cross-functionally collaborate

Demonstration of creativity and analytical thinking

Problem-solving skills

Education

Bachelor’s degree in engineering or related field

Tools

PharmaSuite

Syncade-DeltaV MES

Job description

Overview

Engineer - Syncade or PharmaSuite MES System

Join to apply for the Engineer - Syncade or PharmaSuite MES System role at BioSpace

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 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 sites and continue growing our existing facilities to create 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.
• Develop or assist in the creation and maintenance of the MES interfaces with other Lilly systems.
• Evaluate and translate functional requirements into technical solutions.
• Support MES solutions startup activities.
• Work with site resources towards replication and standardization to drive value and implement the appropriate technical solutions.
• Ensure project and/or validation documentation is maintained during lifecycle and 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 adherence to compliance for internal and external quality guidance.
• Demonstrated and promote Operational Excellence.
• Effectively encourage knowledge sharing and education.
• Ability to problem solve and work through manufacturing situations. 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 for further assistance. 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,750 - $180,400. Full-time equivalent employees also will be eligible for a company bonus and a comprehensive benefit program.