Validation Engineer - Wayland Area

the-pivot-group-careers; Wayland Township (MI); On-site; USD 77,000 - 117,000; Full time

Job summary

The Pivot Group Network in Wayland, MI is seeking an experienced Validation Engineer to develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software. The role emphasizes risk assessments, data analysis, and reporting within a regulated manufacturing setting.

Qualifications include a bachelor’s degree in engineering, 3+ years in validation, and familiarity with FDA GxP and ISO standards.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of validation experience in a regulated manufacturing environment (medical device/pharma).
• Strong understanding of GxP, FDA regulations and ISO standards.
• Experience with validation lifecycle activities (IQ/OQ/PQ) for equipment, processes, and software.
• Excellent technical writing skills for protocols and reports.

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 and author validation reports, including deviations and corrective actions.
• Collaborate with cross-functional teams to define validation strategies.
• Maintain validation master plans and ensure documentation and archiving.
• Investigate and troubleshoot validation failures and implement corrective actions.
• Stay current with industry standards and regulatory guidelines.

Skills

Technical writing

Validation protocols

Risk assessment

Education

Bachelor's degree in engineering or related field

Tools

Python

SQL

Job description

Validation Engineer | Wayland, MI

Salary Range: $77,000 - $117,000 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 Wayland 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 multiple companies in Wayland seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze data and author comprehensive validation reports, including deviations and corrective actions.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to define validation strategies.
• Maintain validation master plans and ensure all validation activities are documented and archived properly.
• Investigate and troubleshoot validation failures, implementing effective solutions and preventative measures.
• Stay current with industry standards and regulatory guidelines related to validation practices.

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).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211), and ISO standards (e.g., ISO 13485).
• Proven experience with validation lifecycle activities including IQ, OQ, PQ for equipment, processes, and software.
• Excellent technical writing skills for creating and executing validation protocols and reports.

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 methodologies.
• Scripting or programming experience (e.g., Python, SQL) for data analysis or 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, GMP Validation Engineer, Quality Validation Engineer, Regulatory Affairs Validation Engineer, Biotechnology Validation Engineer, Pharmaceutical Validation Engineer, Medical Device 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.