Validation Engineer - Traverse City Area

the-pivot-group-careers; Traverse City (MI); On-site; USD 73,000 - 112,000; Full time

Job summary

The Pivot Group Network in Traverse City, MI is seeking a Validation Engineer to develop and execute validation protocols for equipment, processes, and software, ensuring IQ, OQ, and PQ activities are thorough and well documented.

You will collaborate with cross-functional teams to perform risk assessments, analyze data with statistical tools, and maintain validation documentation across the system lifecycle. A Bachelor's degree and 3+ years in a regulated manufacturing environment are required.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline is required.
• 3+ years of validation experience in a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Experience authoring and executing IQ/OQ/PQ protocols for equipment, processes, and software.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, PQ activities and generate validation reports.
• Conduct risk assessments and develop validation strategies in compliance with regulatory requirements.
• Collaborate with cross-functional teams to ensure successful implementation of validated systems.
• Investigate deviations and CAPA for non-conformities and update validation documentation.
• Maintain and update validation documentation throughout the system lifecycle.

Skills

IQ/OQ/PQ

Risk assessment

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

R

Python

Job description

Validation Engineer | Traverse City, MI

Salary Range: $73,000 - $112,000 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 Traverse City 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 working with companies in Traverse City 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 for equipment, processes, and software.
• Perform IQ, OQ, PQ activities and generate comprehensive validation reports.
• Conduct risk assessments and develop validation strategies in compliance with regulatory requirements.
• Collaborate with cross-functional teams to ensure successful implementation of validated systems.
• Investigate deviations and out-of-specification results, implementing corrective and preventive actions.
• Maintain and update validation documentation throughout the system 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 expertise in authoring and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 820, Part 211), and industry standards for validation.
• Experience with risk-based validation approaches and statistical methods for data analysis.

Bonus Qualifications

• Experience with statistical process control (SPC) and design of experiments (DOE).
• Familiarity with data analysis tools (e.g., Minitab, JMP, R, Python).
• Certified Quality Engineer (CQE) or similar professional certification.
• Knowledge of cybersecurity principles as they apply to manufacturing systems.
• Experience with risk management frameworks beyond FMEAs, such as FTA or HAZOP.

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, QA Validation Engineer, Quality Engineer, Compliance Engineer, Regulatory Affairs Specialist, Qualification Engineer