Validation Engineer - Ludington Area

Job Description:

Validation Engineer | Ludington, MI

Salary Range: $74,000 - $113,000 depending on experience

Are you a dynamic leader with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to building meaningful connections and supporting community growth. We are collaborating with leading companies in Ludington seeking experienced Validation Engineers to drive results.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We are working with companies in Ludington that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze data, write validation reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and manage change control processes related to validated systems.
• Maintain validation master plans, schedules, and documentation in an organized and accessible manner.
• Collaborate with engineering, quality, and production teams to ensure successful validation activities.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Demonstrated ability to perform risk assessments and root cause analysis.

Bonus Qualifications

• Experience with statistical process control (SPC) and design of experiments (DOE)
• Familiarity with cybersecurity best practices for industrial control systems
• Knowledge of cloud-based validation tools and platforms
• Project management certification (e.g., PMP, CSM)
• Lean Six Sigma Green Belt or Black Belt certification

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Regulatory Affairs Specialist, Compliance Engineer, Validation Specialist, Validation Lead, CSV Specialist, GxP Validation Engineer

Why The Pivot Group Network

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic-they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at ;br>
If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at The Pivot Group Network offers resources to support your search-market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.

Required Skills:
Resume
Data
Offers
Lean Six Sigma
Support
Root Cause Analysis
Six Sigma
ROOT
Regulatory Requirements
Assurance
Analysis
Compliance
Salary
Hiring
Partnerships
Corrective Actions
Recruiting
Compensation
Validation
Manufacturing
Quality Assurance
Regulations
Preparation
Software
Documentation
Design
Engineering
Project Management
Management

Salary Package:
$ 74,000.00 - 113,000.00 (US Dollar)