Principal Manufacturing Systems Engineer
Core
Lead large capital projects and product teams for manufacturing core systems (OT platforms) in GMP environments, driving efficiency, quality, and automation to support biotech medicine production.
Role type
Principal Manufacturing Systems Engineer (Program/Product Management)
Builds
Manufacturing core systems (Aveva PI, DeltaV, Rockwell, MES), digital infrastructure, and automation solutions for biotech production.
Domain
Biotechnology / Manufacturing Process Automation / Operations Technology
Deliverable
production ML models | product features | infrastructure
Required skills
Program management, Project management, Agile methodology, GMP compliance, Financial management, Vendor performance management, Cross-functional leadership, Regulatory inspection readiness, Global standards development, Roadmap ownership
Preferred skills
Product Owner or Scrum Master experience, GAMP software development lifecycle, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11, Integration of OT platforms with ERP/LIMS, Project Finance experience
Technologies
Aveva PI, DeltaV, Rockwell, MES, ERP, LIMS, Historians
Responsibilities
Lead large capital project and product teams fostering Agile delivery within GMP environments; Partner with stakeholders to prioritize demand and balance local needs with global strategy; Account for financials, resource planning, and delivery against scope/schedule/quality; Drive global standards and best practices for OT project design and lifecycle management; Ensure solution delivery meets GMP compliance and regulatory inspection readiness; Lead cross-functional collaboration between site/corporate Ops, Quality, IT, OT, and external integrators; Own the global OT roadmap including upgrades and harmonization.
Seniority
Principal, hands-on IC with strategic oversight
