Validation Engineer - Norton Shores Area

the-pivot-group-careers; Norton Shores (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network, based in West Michigan, is partnering with Norton Shores employers to recruit a Validation Engineer. You will lead validation activities for equipment, processes, and software, including IQ, OQ, and PQ, ensuring regulatory compliance and robust documentation.

Salary ranges from $78,000 to $118,000 depending on experience, with opportunities across regulated manufacturing environments and collaboration with cross-functional teams in R&D, Quality, and Manufacturing.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in validation within regulated manufacturing.
• Strong knowledge of GxP and FDA/ISO standards.
• Proven IQ/OQ/PQ protocol development experience.
• Proficiency in data analysis for validation activities.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified systems.
• Analyze data and summarize validation reports with conclusions.
• Investigate deviations and ensure traceability across lifecycle.
• Ensure regulatory compliance and internal quality standards.

Skills

Validation protocols

IQ/OQ/PQ execution

Data analysis

Regulatory compliance

Education

Bachelor's degree in engineering or related field

Tools

Minitab

JMP

Job description

Validation Engineer | Norton Shores, MI

Salary Range: $78,000 - $118,000 depending on experience

Are you a seasoned professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to fostering meaningful relationships and supporting community growth. We are collaborating with leading companies in Norton Shores seeking Validation Engineers to lead and enhance their operations.

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 partnering with organizations in Norton Shores that are seeking Validation Engineers. These companies are committed to building strong teams and are looking for professionals who can lead initiatives effectively. By connecting with The Pivot Group Network, you position yourself for roles that match your background and aspirations.

Key Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified systems.
• Analyze data and author validation reports summarizing results and conclusions.
• Investigate and resolve deviations encountered during validation activities.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Maintain validation documentation and ensure traceability throughout the lifecycle.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to support project timelines.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and international standards (e.g., ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical analysis tools and techniques for data analysis and validation activities.

Bonus Qualifications

• Experience with Lean Manufacturing or Six Sigma methodologies.
• Familiarity with data analysis tools like Minitab or JMP.
• Project management certification (e.g., PMP, CAPM).
• Knowledge of specific manufacturing processes relevant to the company's products (e.g., injection molding, sterile filling).
• Advanced degree in a relevant engineering or scientific field.

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Lead Validation Engineer, Principal Validation Engineer, Validation Specialist, Validation Scientist, Validation Consultant, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Test Engineer, Quality Engineer, QA Engineer, Compliance 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.