Senior Engineering/ IT Program Manager
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.