Validation Engineer - Byron Center Area

Job Description:

Validation Engineer | Byron Center, MI

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

Are you a dedicated professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to fostering meaningful relationships and supporting career growth. We partner with leading manufacturing companies in Byron Center, seeking experienced Validation Engineers to strengthen their teams.

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 collaborating with multiple companies in Byron Center seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

Key Responsibilities

• Develop, execute, and review validation protocols for equipment, processes, and software.
• 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 validation deviations and non-conformances.
• Maintain validation master plans and schedules, ensuring timely completion of validation activities.
• Collaborate with engineering, quality, and production teams to integrate validation into the product lifecycle.

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 knowledge of GxP, FDA regulations (e.g., 21 CFR Part 11, Part 820), and industry standards (e.g., ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong technical writing skills for creating clear and concise validation documentation.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLC, SCADA, MES).
• ASQ certifications (e.g., CQE, CSSBB, CQA).
• Knowledge of cybersecurity principles in manufacturing environments.
• Experience with risk management methodologies beyond FMEA (e.g., HAZOP, PHA).

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, Validation Specialist, Validation Lead, Validation Consultant, QA Validation Engineer, Quality Assurance Validation Engineer, Compliance Engineer, Regulatory Affairs Engineer, Test Engineer, Verification 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
Technical Writing
Resume
Data
Offers
Life Sciences
Access
Support
Regulatory Requirements
Assurance
Analysis
Compliance
Salary
Hiring
Partnerships
Recruiting
Compensation
Validation
Manufacturing
Quality Assurance
Writing
Automation
Risk Management
Regulations
Preparation
Data Analysis
Software
Documentation
Engineering
Management

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