Senior Engineering/ IT Program Manager
$80 - $110 per hourFull-time
Three Point Solutions, Inc.
Role Description
Lead large cross-functional engineering programs, supporting manufacturing, digital transformation, and regulated systems across Engineering, Manufacturing, Quality, Regulatory, and IT.
- Manage enterprise engineering programs
- Build roadmaps, milestones, and resource plans
- Deliver within scope, time, and budget
- 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
- Maintain RAID logs
- Drive risk mitigation
- Ensure audit readiness
- Lead global engineering teams
- Manage stakeholders
- Escalation point for risks and constraints
- 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
Requirements
- PMP or Scrum Master preferred
- 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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