Validation Engineer - Grand Rapids Area

the-pivot-group-careers; Grand Rapids (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network is collaborating with Grand Rapids manufacturing firms to identify a skilled Validation Engineer. The role centers on creating and executing validation protocols for equipment, processes, and software in regulated manufacturing environments.

Candidates should hold a Bachelor's degree in Engineering or Life Sciences and have 2+ years of validation experience with knowledge of GxP regulations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years of experience in validation within a regulated manufacturing environment (e.g., Pharma, Biotech, Medical Device).
• Demonstrated knowledge of GxP regulations (e.g., FDA 21 CFR Parts 210, 211, 820) and industry standards (ICH, ISO).
• Proficiency in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Experience with quality management systems and deviation investigation processes.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• Conduct risk assessments and develop validation strategies in accordance with regulatory requirements.
• Analyze validation data, prepare reports, and present findings to cross-functional teams.
• Investigate and resolve validation deviations and non-conformances.
• Maintain validation documentation and ensure compliance with internal procedures and external regulations.
• Support the continuous improvement of validation processes and methodologies.

Job description

Validation Engineer | Grand Rapids, MI

Salary Range: $81,000 - $121,000 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 Grand Rapids 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 are collaborating with manufacturing firms in Grand Rapids that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

Key Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.


• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.


• Conduct risk assessments and develop validation strategies in accordance with regulatory requirements.


• Analyze validation data, prepare reports, and present findings to cross-functional teams.


• Investigate and resolve validation deviations and non-conformances.


• Maintain validation documentation and ensure compliance with internal procedures and external regulations.


• Support the continuous improvement of validation processes and methodologies.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.


• 2+ years of experience in validation within a regulated manufacturing environment (e.g., Pharma, Biotech, Medical Device).


• Demonstrated knowledge of GxP regulations (e.g., FDA 21 CFR Parts 210, 211, 820) and industry standards (e.g., ICH, ISO).


• Proficiency in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.


• Experience with quality management systems and deviation investigation processes.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).


• Familiarity with automation and control systems (e.g., PLCs, SCADA).


• Knowledge of cybersecurity principles as they apply to manufacturing systems.


• Experience with risk management methodologies (e.g., FMEA, PHA).

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Quality Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, Validation Specialist

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.