Validation Engineer - St. Johns Area

the-pivot-group-careers; St. Johns (MI); On-site; USD 73,000 - 112,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer for opportunities in St. Johns, Michigan. The role focuses on developing and executing validation protocols, ensuring compliance with FDA/GMP, and collaborating with R&D, manufacturing, and quality teams.

Qualified candidates hold a Bachelor's in engineering, have 3+ years in regulated validation, and are proficient in IQ/OQ/PQ, data analysis, and programming (Python/SQL). The salary range is $73,000 to $112,000 depending on experience.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of validation experience in a regulated manufacturing environment.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis and data interpretation for validation purposes.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data, write reports, and present findings.
• Investigate deviations and non-conformances during validation activities.
• Ensure regulatory compliance with FDA, GMP, and internal quality standards.
• Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• Maintain validation documentation throughout the equipment and process lifecycle.

Skills

Statistical analysis

Data interpretation

Regulatory knowledge

Education

Bachelor's degree in engineering or related discipline

Tools

Python

SQL

Job description

Validation Engineer | St. Johns, MI

Salary Range: $73,000 - $112,000 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 St. Johns 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 St. Johns 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 (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data, write reports, and present findings.
• Investigate deviations and non-conformances during validation activities.
• Ensure compliance with regulatory requirements (e.g., FDA, GMP) and internal quality standards.
• Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• Maintain validation documentation throughout the equipment and process lifecycle.

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).
• Demonstrated knowledge of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Experience with validation lifecycle activities, including IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis and data interpretation for validation purposes.

Bonus Qualifications

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with data integrity principles and ALCOA+.
• Knowledge of GAMP 5 guidelines.
• Experience with risk-based validation approaches.
• Scripting or programming experience (e.g., Python, SQL) for data analysis or test automation.

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

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.