Validation Engineer - Caledonia Area

Job Description:

Validation Engineer | Caledonia, MI

Salary Range: $73,000 - $112,000 depending on experience

Are you ready to take on a challenging and rewarding opportunity in {{role_field}}? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to building meaningful connections in manufacturing. We partner with leading companies in Caledonia seeking 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 Caledonia 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, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation plans based on regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to ensure successful project execution and adherence to quality standards.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Maintain and update validation documentation to ensure compliance with cGMP, FDA, and other regulatory guidelines.
• Provide technical expertise and guidance on validation strategies and requirements to various departments.
• Participate in internal and external audits, providing necessary documentation and support.
• Develop and deliver training on validation principles and procedures to manufacturing and quality personnel.

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).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and international standards (e.g., ISO 13485).
• Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical analysis tools and methodologies for validation activities.

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, Software Validation Engineer, Test Automation Engineer, Quality Assurance Engineer, QA Validation Engineer, Regulatory Affairs Specialist, Compliance Engineer, 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
Offers
Life Sciences
Test Automation
Support
Regulatory Requirements
Assurance
Analysis
Compliance
Salary
Hiring
Partnerships
Recruiting
Compensation
Validation
Manufacturing
Quality Assurance
Automation
Regulations
Preparation
Software
Documentation
Engineering
Training

Salary Package:
$ 73,000.00 - 112,000.00 (US Dollar)