Job Title : Senior Manufacturing Systems Engineer
Location : Somerset, NJ (On-Site)
Overview
We are seeking a Senior Manufacturing Systems Engineer to lead the design, delivery, and maintenance of Manufacturing Execution Systems (MES). This role requires hands-on MES expertise, including implementation, Electronic Batch Record (EBR) design, system integration, and ongoing support. The ideal candidate will be a strong collaborator, working with both technical and business teams to ensure MES solutions meet user requirements and compliance standards.
Key Responsibilities
- Lead the delivery, support, and optimization of global MES solutions in alignment with IT and manufacturing strategies.
- Define MES standards and ensure consistency across global and local teams.
- Design, implement, and maintain integrations between MES and other systems, including automation platforms.
- Partner with Business Process Owners to manage demand intake, enhancements, and support requests.
- Drive continuous improvement and vendor collaboration to optimize MES.
- Manage MES project lifecycles, including timelines, testing, and compliance with GxP requirements.
- Communicate MES strategies and ensure alignment with business stakeholders.
- Assess impacts of changes on MES and connected systems, ensuring robust performance.
Qualifications
Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field.7+ years of MES experience in a Pharmaceutical or Biotech GxP environment.Proven track record of MES implementation and support with Quality / Compliance requirements.Strong knowledge of Computer Systems Validation, Qualification activities, and change control.Experience in Cell Therapy manufacturing preferred.Familiarity with regulatory requirements (GxP, SOX, data privacy).Excellent organizational, communication, and presentation skills.Ability to collaborate across functions, resolve conflicts, and influence decisions effectively.Apply Now
If you have a passion for driving MES excellence in a regulated manufacturing environment and thrive in a collaborative setting, we’d love to hear from you. Apply today to join a team making a direct impact on advanced manufacturing.