Sr. Manufacturing Systems Engineer

2 days ago

Somerset, New Jersey, United States Meet Life Sciences Full time

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.

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