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Senior Engineering/ IT Program Manager

$80 - $110 per hour
Full-time

Three Point Solutions, Inc.

Role Description

  • Lead large cross-functional engineering programs
  • Support manufacturing, digital transformation, and regulated systems
  • Work across Engineering, Manufacturing, Quality, Regulatory, and IT

Program Leadership

  • Manage enterprise engineering programs
  • Build roadmaps, milestones, and resource plans
  • Deliver within scope, time, and budget

Manufacturing & Systems

  • Lead MES and automation initiatives
  • Oversee CSV, IQ/OQ/PQ validation
  • Ensure FDA, ISO 13485, GxP, 21 CFR Part 11 compliance
  • Support digital manufacturing transformation

Risk & Compliance

  • Maintain RAID logs
  • Drive risk mitigation
  • Ensure audit readiness

Cross-Functional

  • Lead global engineering teams
  • Manage stakeholders
  • Escalation point for risks and constraints

Governance & Reporting

  • Executive status reporting
  • Maintain program plans and documentation
  • Track budget and financials

Qualifications

  • Bachelor's in Engineering / CS
  • 10+ years in regulated industries (Med Device / Pharma)
  • Strong in MES, CSV, automation
  • Regulatory knowledge (FDA, GxP, Part 11)
  • Large team leadership (50+ preferred)
  • Agile & Waterfall experience
  • Enterprise-scale program delivery
  • Willing to travel to Puerto Rico

Preferred

  • PMP or Scrum Master
  • Global manufacturing deployments
  • ERP / SAP / LIMS exposure
  • Site expansion or transfer programs
  • Digital transformation or PMO background

Key Skills

  • Executive communication
  • Stakeholder management
  • Strategic roadmaps
  • Regulatory mindset
  • Budget control
  • Change management
  • Influence without authority
Vacancy posted 4 hours ago
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