Associate System Engineer

Eli Lilly and Company; Branchburg Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company is seeking a System Engineer to design and develop IT solutions at their Branchburg site. This role involves enhancing manufacturing systems and requires strong technical skills, experience with MES and LIMS, and the ability to communicate effectively with stakeholders. The position is full-time, on-site, and offers opportunities to influence system integration and operational efficiencies.

Qualifications

• 3+ years experience leading Computer System Validation of IT platforms.
• Experience with Manufacturing Execution Systems integration.
• Strong understanding of regulatory requirements in GMP.

Responsibilities

• Design and develop IT solutions for business problems.
• Develop understanding of business processes at Branchburg.
• Collaborate with developers and subject matter experts.

Skills

Technical guidance to team members

Excellent communication skills

Analytical and problem-solving skills

Staying up to date with industry trends

Experience in Computer System Validations

Interpersonal skills

Education

Bachelor’s degree in Software Engineering or related field

High school diploma with 5+ years experience

Tools

MES Syncade

LIMS

Tableau

Power BI

Java

Python

Job description

Senior Talent Sourcing | CIPD | DEI Ambassador | Sourcing Blackbelt | Passionate about Candidate Experience & Development

Position Brand Description:

As System Engineer on the Tech at Lilly team, the major function of this position is to design and develop IT solutions (integrated process, applications, data and technology) to business problems. You will use your technical expertise, analytical skills, and leadership abilities to create key components for these systems, evaluate different technologies, and work closely with other members of the IT and Business teams to ensure that the systems are implemented correctly and effectively.

Specifically at the Branchburg site, this position would aid the site adoption and continued enhancement of new and existing systems to help progress the site’s paperless manufacturing objectives and Digital Plant Strategies including but not limited to Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS). It will also partner cross-functionally in line with the Manufacturing Strategy for Operational Excellence (MSOE) to enable the Site mission and vision, ensuring IT deliverables are delivered on time and in accordance with applicable Lilly Quality Standards and Practices.

How You Will Succeed:

• Bring your technical knowledge and experience to design, develop and influence the implementation and enhancements to new and existing systems by partnering with end users and IT Support teams to analyze, prioritize, design, and implement system modifications to enhance operational efficiency, ensure data integrity, and improve the end-user experience.
• Act as core member of the Tech at Lilly Process team and participate in a cross functional role to help assess and execute required changes, improvements, process modifications, equipment upgrades, changeovers, and planned shutdowns to systems that support manufacturing and QC Areas
• Develop an in-depth understanding of the business processes at Branchburg. Apply knowledge to assigned solutions to support the business processes. Work with Process Engineers, Automation Engineers, Operations, Quality, and TS/MS evaluate changes to the processes and impact to E-Systems.
• Drive the site adoption of assigned solutions, lead integration efforts of enterprise platforms and ensure alignment with Site and Tech at Lilly strategies, while leveraging awareness of internal and external trends in partnership with the Business SMEs.
• Collaborate with developers and subject matter experts (global and local), MES and QC support teams, to establish the technical vision and analyze enhancement road map and align with Manufacturing schedule.
• Must be able to evaluate the organization's needs, anticipate potential issues, conduct walkthroughs, and create key components that ensures the systems and architecture meets the requirements.
• Must have a strong business understanding and demonstrate business learning agility e.g. manufacturing processes, technical transfers, engineering standards.
• Must be able to communicate complex technical information to both technical and non- technical stakeholders and influence decision making at senior leadership level.
• Must be able to stay up-to-date with new technologies and evaluate which ones are best suited for the organization's needs.
• Critically evaluate user requests and use technical and process knowledge to determine underlying true business needs.
• Ensure adherence to all quality, compliance, data integrity requirements.
• Provide ongoing communication on issues, and major deliverables to management and staff.
• Pursue an injury free workplace and minimize our environmental impact.
• Review and approve documentation related to areas of responsibility (Validation Lifecycle documents, SOPs, policies, executed IQPQ protocols, etc.) as appropriate.
• Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.

What You Should Bring

• Experience with providing technical guidance to other members of the organization, including developers, project managers, and technical support staff.
• Staying up to date with industry trends and emerging technologies to ensure that the organization's systems remain competitive and effective.
• Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
• Analytical and problem-solving skills to identify and resolve complex technical issues.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Experience with Computer System Validations.
• Experience with Manufacturing Execution Systems and how to integrate with Automation and other Local/Global IT platforms.
• Demonstrable experience in tools / platforms such as MES Syncade, LIMS and Integration technologies enabling data flow with downstream systems (e.g. OSI PI, Data Lakes, Process Monitoring systems such as JMP, Tableau, Power BI)

Your Basic Qualifications:

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field
• OR High school diploma with a minimum of 5+ years of experience working with Pharmaceutical Manufacturing systems (e.g. Data solutions, LIMS systems, MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X).
• Minimum 3+ years experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance.
• 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.

Additional Preferences

• Expertise in integrating new technologies including MES & LIMS systems with other enterprise and automation systems, such as ERP (Enterprise Resource Planning), Automation and SCADA (Supervisory Control and Data Acquisition) systems, to ensure seamless data flow and system interoperability.
• Experience with programming languages such as .NET, Java, Python, and SQL.
• Experience with or ability to develop skills with low-code software tools such as Tulip, etc.
• Expertise with related technologies and standards, including ISA-95, OPC, and data historians.
• Understanding of cybersecurity concepts and best practices
• Strong understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.
• Experience with Computer System Validations.
• Experience with technical mentoring and developing technical team members.
• Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.

Other Information

• Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.