Validation Engineer - Hart Area

Job Description:

Validation Engineer | Hart, MI

Salary Range: $81,000 - $121,000 depending on experience

Are you a detail-oriented professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career advancement. We are collaborating with leading companies in Hart seeking experienced Validation Engineers.

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 collaborate with manufacturing companies in the Hart region seeking Validation Engineers. These employers partner with us because they want real insight into candidates-not just resumes. By joining our network, you gain access to roles worth considering.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Support the lifecycle management of validated systems, including revalidation and change control.
• Collaborate with engineering, quality, and production teams to ensure successful project execution.
• Maintain up-to-date knowledge of industry best practices and regulatory guidelines (e.g., FDA, ISO).

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Demonstrated expertise in authoring, executing, and reviewing validation protocols and reports (IQ, OQ, PQ, CSV).
• Strong understanding of GxP, FDA regulations (21 CFR Part 820, Part 11), ISO 13485, and other relevant industry standards.
• Experience with statistical methods for validation and data analysis.

Bonus Qualifications

• Additional certifications or training

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, Cleaning Validation Engineer, Test Automation Engineer (Validation), Quality Assurance Engineer (Validation), Compliance Engineer, Regulatory Affairs Specialist (Validation), Metrology Engineer, Calibration Engineer, Validation Specialist, Validation Lead, Validation Consultant, GMP Validation Engineer, GxP Validation Engineer, Software 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:
GMP
Resume
Data
Offers
Life Sciences
Test Automation
Access
Support
Calibration
Regulatory Requirements
Assurance
Analysis
Compliance
Salary
Hiring
Partnerships
Recruiting
Compensation
Validation
Manufacturing
Quality Assurance
Automation
Regulations
Preparation
Data Analysis
Software
Engineering
Training
Management

Salary Package:
$ 81,000.00 - 121,000.00 (US Dollar)