Validation Engineer - Ludington Area

the-pivot-group-careers; Ludington (MI); On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Network in Ludington, MI is seeking a Validation Engineer to lead validation initiatives for manufacturing equipment, processes, and software. You will develop and execute IQ, OQ, and PQ protocols, perform risk assessments, and ensure compliance with regulatory requirements.

You will collaborate with engineering, quality, and production teams, maintain validation master plans, and manage change control.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in validation within regulated manufacturing.
• Strong knowledge of GxP and FDA/ISO standards.
• Experience developing and executing IQ/OQ/PQ protocols.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze data, write validation reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and manage change control processes.
• Maintain validation master plans, schedules, and documentation in an organized manner.
• Collaborate with engineering, quality, and production teams to ensure validation activities.

Skills

Validation data analysis

Risk assessment

Cross-functional collaboration

IQ/OQ/PQ execution

Regulatory compliance

Education

Bachelor's degree in engineering

Job description

Validation Engineer | Ludington, MI

Salary Range: $74,000 - $113,000 depending on experience

Are you a dynamic leader 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 and supporting community growth. We are collaborating with leading companies in Ludington seeking experienced Validation Engineers to drive results.

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 working with companies in Ludington that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software.


• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.


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


• Investigate deviations, implement corrective actions, and manage change control processes related to validated systems.


• Maintain validation master plans, schedules, and documentation in an organized and accessible manner.


• Collaborate with engineering, quality, and production teams to ensure successful validation activities.

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 devices, pharmaceuticals).


• Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).


• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.


• Demonstrated ability to perform risk assessments and root cause analysis.

Bonus Qualifications

• Experience with statistical process control (SPC) and design of experiments (DOE)


• Familiarity with cybersecurity best practices for industrial control systems


• Knowledge of cloud-based validation tools and platforms


• Project management certification (e.g., PMP, CSM)


• Lean Six Sigma Green Belt or Black Belt certification

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, Validation Lead, CSV Specialist, GxP Validation Engineer