Systems Engineer (R1-R4)

Initial Therapeutics, Inc.; Concord (NC); Hybrid; USD 154,669 - 177,869; Full time

Benefits offered by this job

401(k) plan

Pension

Medical/dental/vision coverage

Well-being programs

Job summary

Initial Therapeutics, Inc. is seeking a qualified candidate for a role focused on the development and maintenance of Manufacturing Execution System (MES) applications in Concord, NC. The successful applicant will integrate production operations with business systems and ensure compliance with industry regulations, including FDA guidelines.

To qualify, candidates need a bachelor's degree in a related field and significant experience with MES applications in a pharmaceutical context. The position offers an annual salary range of $154,669.00 – $177,869.35, alongside various benefits.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Science, Computer Science, or related scientific field.
• Minimum 5 years of experience with MES applications in a pharmaceutical setting.
• Experience with manufacturing standards, including ISA‑95 and Open Platform Communications.

Responsibilities

• Design and maintain Manufacturing Execution System (MES) applications.
• Integrate production operations with business systems.
• Ensure compliance with FDA regulations and Good Manufacturing Practices.

Skills

Manufacturing Execution Systems (MES)

Pharmaceutical manufacturing standards

Computer systems validation

Integration of MES systems

Knowledge of FDA guidelines

Education

Bachelor's degree in Pharmacy or related field

Tools

Rockwell Automation Pharma Suite

Emerson Syncade

Siemens Camstar

Werum PAS-X

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities

• Design, develop, implement, enhance, and maintain Manufacturing Execution System (MES) applications for pharmaceutical manufacturing.
• Integrate pharmaceutical production operations with business systems.
• Conduct testing, troubleshooting, and maintenance of MES applications to ensure system reliability and data accuracy.
• Document processes and procedures for pharmaceutical manufacturing systems to meet quality and compliance standards.
• Ensure MES systems follow pharmaceutical industry‑specific regulations, including FDA guidelines and Good Manufacturing Practices (GMP) requirements, internal policies and procedures, and local requirements.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Science, Computer Science, or a related scientific field.
• Minimum 5 years of progressively responsible experience with MES applications in a pharmaceutical setting.
• 5 years of experience with manufacturing standards, including ISA‑95, Open Platform Communications, and data historians.
• 5 years of experience with computer systems validation.
• 3 years of experience with Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS‑X.
• 3 years of experience integrating MES systems with other enterprise systems, including ERP and SCADA.
• Up to 15% domestic and international travel.
• Part‑time telecommuting permitted.

Position Details

Job location: Concord, NC.

Compensation and Benefits

Annual salary range: $154,669.00 – $177,869.35.

Full‑time employees are eligible for company bonuses based on performance.

Benefits include a company‑sponsored 401(k), pension, vacation, medical/dental/vision prescription drug coverage, flexible spending accounts, life insurance, death benefits, leave of absence, and well‑being programs such as employee assistance program and fitness benefits.

EEO Statement

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.