Summary
Overview
Work History
Education
Skills
Timeline
Leadership Experience
Generic

Sierra (Maddie) Evans

Rockingham

Summary

Engineering professional with validation experience supporting multi-stage manufacturing, compliance, and site execution at Merck. Skilled in managing workstreams, developing technical documentation, and partnering across functions to deliver timely, audit-ready outcomes. Brings strong project management, communication, and adaptability skills, with leadership experience and an MBA in progress.

Overview

5
5
years of professional experience

Work History

Process Validation Engineering Specialist

Merck & Co.
02.2022 - Current
  • Ensure ongoing process control during commercial manufacturing post-PPQ by monitoring performance trends and supporting continued process validation (CPV) activities.
  • Collaborate with multiple integrated process teams to summarize, investigate, and communicate manufacturing performance across assigned processes.
  • Prepare CPV reports in support of Gardasil, Gardasil9, and site antibiotic product Annual Product Quality Reviews, ensuring accuracy and timely completion.
  • Coordinate source document workstreams and delegated tasks to support Gardasil expansion filing timelines for various stakeholders.

Cleaning Validation Engineering Contractor / Associate Specialist

Merck & Co.
02.2022 - Current
  • Lead validation workstreams to complete the realization of the Elkton Gardasil Expansion project.
  • Authored technical protocols, memos, and reports summarizing batch results and capturing manufacturing process changes.
  • Designed and executed studies aimed at addressing malfunctions in critical manufacturing equipment.
  • Collaborated with cross functional teams and supplementary business units to analyze product process performance and meet crucial regulatory filing deadlines on key validation documentation.
  • Provide guidance and support for all cross-functional teams on site to remain compliant and audit ready.
  • Author process validation statistical analysis reports that demonstrate process control to regulatory agencies.

Merck Production Systems (MPS) Engineering Intern

Merck & Co.
01.2021 - 07.2021
  • Began the implementation of a lean supermarket to streamline usage of raw materials.
  • Simulated the supermarket prototype for sterile supply, incorporating Lead Six Sigma principles to aid in inventory tracking.
  • Collaborated with cross-functional teams across site to assess implementation strategies to optimize workflow.

Education

Bachelor of Science - Biotechnology, Pre-Medicine and Medical Spanish

James Madison University
05-2021

Master of Business Administration Candidate - Innovation

James Madison University
05-2027

Skills

  • Good Manufacturing Practices (GMP)
  • Process Validation
  • Cleaning Validation
  • Project Management
  • Data Analysis
  • Adaptability
  • Communication
  • Organization
  • Technical Writing
  • Budgeting
  • Event Planning/Facilitation
  • Software/Programming: Microsoft Suite, DeltaV, Systems Applications and Products in Data Processing (SAP), Global Manufacturing Intelligence and Integration (GMII), Shiny Application, Datalynx, JMP

Timeline

Process Validation Engineering Specialist

Merck & Co.
02.2022 - Current

Cleaning Validation Engineering Contractor / Associate Specialist

Merck & Co.
02.2022 - Current

Merck Production Systems (MPS) Engineering Intern

Merck & Co.
01.2021 - 07.2021

Master of Business Administration Candidate - Innovation

James Madison University

Bachelor of Science - Biotechnology, Pre-Medicine and Medical Spanish

James Madison University

Leadership Experience

Next Generation Network (NGN) Employee Business Resource Group (EBRG):

Communications Co-Lead, Elkton, VA Leadership Team

May 2024 – Present

  • Drive site-wide communications to strengthen employee engagement, inclusion, and collaboration.
  • Implement tools and processes that improve leadership-team coordination and communication efficiency.
  • Lead messaging on events, networking opportunities, and professional development resources for site personnel.

Chief of Staff, US Region Leadership Team

June 2025 – Present

  • Serve as primary budget contact for eleven chapters, ensuring alignment and accountability across the region.
  • Provide strategic communication support to drive consistency, execution, and follow-through.
  • Partner with chapter leaders to coordinate priorities and advance regional initiatives.

Leadership Summit Planner, US Region Leadership Team

June 2024 – May 2025

  • Lead planning and execution of semi-annual NGN Leadership Summits for the U.S. region.
  • Designed a three-day summit agenda to support strategic discussion and participant engagement.
  • Managed event logistics, including travel, lodging, and catering, for 30 U.S. Chapter Leads.
Sierra (Maddie) Evans