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Systems Engineering Manager

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ATS Automation Tooling Systems Inc.

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Location:
United States , Charlotte

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

SP Industries, Inc. is expanding our team in and has an opening for a Senior Systems Engineer. We’re looking for a Senior Systems Engineer who wants true technical ownership – someone ready to step beyond a single discipline and take responsibility for how complex systems come together, perform, and succeed in the field. In this role, you’ll be the technical glue across mechanical design, controls, automation, process engineering, quality, and manufacturing. You’ll work at the system level to ensure our pharmaceutical equipment meets customer needs, regulatory expectations, and long‑term performance goals—from early concept through qualification and deployment.

Job Responsibility:

  • Translate customer, GMP, and regulatory requirements into clear, verifiable system-level requirements
  • Define and maintain system architectures spanning mechanical, controls, automation, utilities, vacuum, refrigeration, and process interfaces
  • Manage requirements traceability through design, verification, validation, and change management
  • Lead cross-disciplinary integration across mechanical, electrical, controls, software, and process engineering teams
  • Facilitate system-level design reviews, trade studies, and risk analyses, including FMEAs
  • Identify and mitigate integration risks impacting performance, reliability, safety, and compliance
  • Provide technical oversight for major subsystems such as chambers, shelves, condensers, fill paths, motion systems, vacuum, and refrigeration
  • Review and approve system-level specifications and technical documentation
  • Support manufacturing, testing, FAT/SAT, and field deployments
  • Partner with quality, validation, supply chain, and manufacturing to ensure designs are buildable, testable, and serviceable
  • Participate in customer‑facing technical discussions and architecture reviews
  • Act as a go‑to technical resource for system‑level questions and decisions

Requirements:

  • Bachelor's degree in Mechanical Engineering or related discipline
  • 8–12+ years developing complex pharmaceutical, biotech, or regulated process equipment
  • Experience integrating mechanical, controls, and process subsystems
  • Working knowledge of GMP-regulated environments, including FDA, ISPE, ASME, and ASTM expectations
  • Strong communication skills across technical and non-technical stakeholders

Nice to have:

  • Direct experience with aseptic fill-finish and/or lyophilization systems
  • Working knowledge of systems engineering methodologies, including requirements management and V-model practices
  • Experience leading or facilitating system-level FMEAs and formal design reviews
  • Proficiency with 3D CAD tools such as SolidWorks or Creo
  • Exposure to vacuum, thermal, refrigeration, and pressure-vessel-based equipment common in GMP environments
What we offer:
  • Robust health and welfare benefits package that includes Life, Health, Dental, Vision
  • 401(K) including company match
  • Paid Time Off annually + Paid Holidays
  • Career Advancement Opportunities
  • Tuition Assistance

Additional Information:

Job Posted:
May 17, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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