Validation Engineer - Holt Area

the-pivot-group-careers; Holt (MI); On-site; USD 75,000 - 114,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer in Holt, MI to develop and execute validation protocols for equipment, processes, and software in a regulated manufacturing setting. You will perform IQ/OQ/PQ activities for new and modified systems and author comprehensive validation reports.

Ideal candidates have a bachelor's degree in a technical field, 2+ years in validation within GMP environments, and strong knowledge of GxP (FDA/ISO) regulations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years experience in validation activities within a regulated manufacturing environment.
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with validation methodologies including IQ, OQ, PQ, process validation, and software validation.
• Proficiency in writing and executing validation protocols and reports.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified systems.
• Analyze validation data and author comprehensive validation reports.
• Investigate and resolve deviations and non-conformances during validation activities.
• Ensure all validation activities comply with cGMP, FDA, and internal quality standards.
• Maintain and update validation documentation throughout the system lifecycle.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing.

Skills

IQ/OQ/PQ validation

Validation protocols

Data analysis (SPC)

Education

Bachelor's degree in Engineering/Life Sciences

Tools

MiniTab

JMP

SCADA

DCS

PLCs

Job description

Validation Engineer | Holt, MI

Salary Range:

$75,000 - $114,000 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 Holt 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 partner with manufacturers across Holt seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.

Key Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified systems.
• Analyze validation data and author comprehensive validation reports.
• Investigate and resolve deviations and non-conformances during validation activities.
• Ensure all validation activities comply with cGMP, FDA, and internal quality standards.
• Maintain and update validation documentation throughout the system lifecycle.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with various validation methodologies including IQ, OQ, PQ, process validation, and software validation.
• Proficiency in writing and executing validation protocols and reports.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, JMP).
• Familiarity with automation systems and software validation (e.g., SCADA, DCS, PLCs).
• Certified Quality Engineer (CQE) or similar professional certification.
• Knowledge of cybersecurity principles as they apply to manufacturing systems.

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 Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Regulatory Affairs Specialist, Compliance Engineer, Validation Specialist, Automation 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 https://www.thepivotgroup.org.

Thank you for considering this approach to career advancement.