Validation Engineer - Newaygo Area

Job Description:

Validation Engineer | Newaygo, MI

Salary Range: $80,000 - $120,000 depending on experience

Are you a seasoned 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 community growth. We are collaborating with leading companies in Newaygo seeking Validation Engineers to lead and enhance their operations.

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 Newaygo 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 equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze validation data, write comprehensive validation reports, and present findings to stakeholders.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to define validation strategies.
• Maintain validation documentation in accordance with internal procedures and external regulations.
• Support continuous improvement initiatives by optimizing validation processes and methodologies.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation lifecycle activities, including IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis tools for process validation and data analysis.

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).
• Experience with Computerized Maintenance Management Systems (CMMS) or Enterprise Asset Management (EAM) software.

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Validation Engineer, Equipment Validation Engineer, Process Validation Engineer, Cleaning Validation Engineer, Computer System Validation Engineer, Software Validation Engineer, Validation Specialist, Validation Lead, Validation Manager, Quality Engineer, QA Engineer, Regulatory Affairs Specialist, Compliance Engineer, Test Engineer, Verification Engineer, Automation Engineer, Pharmaceutical Validation Engineer, Biotech Validation Engineer, Medical Device 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
Access
Support
Six Sigma
Asset Management
Operations
Regulatory Requirements
Analysis
Compliance
Salary
Hiring
Partnerships
Recruiting
Compensation
Validation
Continuous Improvement
R
Manufacturing
Automation
Programming
Regulations
Preparation
Data Analysis
Software
Documentation
Maintenance
Engineering
Project Management
Management

Salary Package:
$ 80,000.00 - 120,000.00 (US Dollar)