Priscilla Hamilton

About Priscilla Hamilton

Strategic Chemical Engineer and Technical Operations leader with progressive experience at Merck & Co. across biologics, sterile, and vaccine manufacturing operations. I specialize in aligning manufacturing strategy, compliance infrastructure, and operational scale-up within complex, highly regulated cGMP environments. My career reflects increasing enterprise-level responsibility spanning reliability engineering, deviation governance, validation and PPQ execution, operations leadership, shutdown strategy, and global external manufacturing oversight. I have led high-complexity investigations (QNs/CAPAs), governed change control systems, strengthened inspection readiness frameworks, and implemented risk-based asset management programs that improved uptime, reduced recurrence, and enhanced throughput performance across multi-asset production platforms. As an Operations Manager during accelerated demand growth, I supported ~40% batch output expansion through workforce realignment, shift restructuring, KPI-driven performance management, and structured escalation models—while sustaining quality, safety, and regulatory standards. I later transitioned into enterprise maintenance strategy, architecting integrated scheduling models, leading shutdown planning, and deploying KPI dashboards to optimize backlog health, calibration compliance, and equipment reliability. In parallel, I serve as technical liaison for international external manufacturing sites across LATAM, supporting strategic site disentanglement and global technology transfers. I facilitate cross-functional governance across quality, regulatory, supply chain, engineering, and CMOs—mitigating supply risk, driving accountability, and ensuring validation readiness without direct authority. As MBA-trained and bilingual (English & Portuguese), I bring a systems-level perspective to global pharmaceutical networks seeking disciplined growth, operational resilience, and scalable compliance execution.

Experience

1. External Manufacturing (Exm) Dp Technical Operations Support Latam

   Merck

   Nov 2025 — Present · US

   Serve as primary technical liaison supporting external packaging sites in Brazil and Mexico during strategic site disentanglement and global supply continuity initiatives.• Lead complex deviation investigations and change control governance across sterile and small molecule packaging operations, ensuring technical rigor, documentation integrity, regulatory alignment, and timely closure within global quality systems.• Support large-scale technology transfers to alternate global packaging sites, coordinating validation readiness assessments, risk evaluations, comparability considerations, milestone tracking, and cross-site documentation harmonization to enable uninterrupted supply continuity.• Facilitate structured governance forums across CMOs, global quality, regulatory, supply chain, and technical operations stakeholders—proactively identifying performance gaps, escalating systemic risks, and influencing corrective accountability without direct reporting authority.• Conduct comprehensive site risk assessments evaluating process robustness, packaging validation alignment, deviation recurrence trends, training compliance, and inspection readiness posture throughout transitional phases.• Develop and maintain detailed transition dashboards tracking validation milestones, deviation metrics, supply risk indicators, and corporate disentanglement timelines to ensure alignment with enterprise exit strategy commitments.

Education

• Life Cycle Institute

  Reliability engineering certificate, Root Cause Analysis

• University of Virginia

  Bachelor of Science (BS), Chemical Engineering

  2012 — 2015

• Eastern Mennonite University

  Master of Business Administration - MBA, Organizational Leadership

  2016 — 2018