Validation Engineer - Rockford Area

Job Description:

Validation Engineer | Rockford, MI

Salary Range: $77,000 - $117,000 depending on experience

Are you a skilled professional 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 in the manufacturing community. We are collaborating with companies in Rockford 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 are partnering with organizations in Rockford that are seeking Validation Engineers. These companies are committed to building strong teams and are looking for professionals who can lead initiatives effectively. By connecting with The Pivot Group Network, you position yourself for roles that match your background and aspirations.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements (e.g., FDA, ISO).
• Analyze validation data, write comprehensive validation reports, and present findings to cross-functional teams.
• Investigate deviations and out-of-specification results during validation activities, implementing corrective actions.
• Collaborate with engineering, quality, and production teams to ensure successful technology transfers and new product introductions.
• Maintain and update validation master plans, procedures, and documentation to reflect current regulatory standards and best practices.
• Support internal and external audits by providing validation documentation and expertise.

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 device, pharmaceutical).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Demonstrated ability to perform root cause analysis and implement corrective actions for validation deviations.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., SCADA, DCS, PLC programming).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Project management experience or certification (e.g., PMP, CAPM).
• Working knowledge of cybersecurity principles in manufacturing environments.

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Quality Validation Engineer, Senior Validation Engineer, Principal 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:
Minitab
Resume
Data
Offers
Lean Six Sigma
Support
Root Cause Analysis
Six Sigma
ROOT
Regulatory Requirements
Analysis
Compliance
Salary
Hiring
Partnerships
Corrective Actions
Recruiting
Compensation
Validation
Manufacturing
Automation
Programming
Regulations
Preparation
Data Analysis
Software
Documentation
Engineering
Project Management
Management

Salary Package:
$ 77,000.00 - 117,000.00 (US Dollar)