Validation Engineer - Paw Paw Area

the-pivot-group-careers; Paw Paw (MI); On-site; USD 80,000 - 120,000; Full time

Job summary

The Pivot Group Network in West Michigan is seeking a Validation Engineer to support Paw Paw, MI area manufacturers. You will design and execute validation protocols for equipment, processes and software, and lead IQ/OQ/PQ activities within a regulated manufacturing setting.

Ideal candidates hold a Bachelor's in Engineering or Life Sciences with 3+ years of validation experience and solid knowledge of GxP, FDA 21 CFR Part 11, Part 820, ISO 13485, plus strong data analysis and risk assessment

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of validation experience in a regulated manufacturing environment.
• Experience with GxP regulations, FDA 21 CFR Part 11, Part 820, ISO 13485.

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 generate comprehensive validation reports.
• Conduct risk assessments and develop mitigation strategies for manufacturing processes.
• Ensure compliance with cGMP, FDA regulations, and industry standards.
• Troubleshoot validation discrepancies and implement corrective actions.
• Collaborate with cross-functional teams on product introductions and process improvements.

Skills

Validation protocols

IQ/OQ/PQ

GxP regulations

FDA 21 CFR Part 11

Part 820

ISO 13485

Statistical methods

Risk assessment (FMEA)

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Minitab

JMP

Job description

Validation Engineer | Paw Paw, MI

Salary Range: $80,000 - $120,000 depending on experience

Are you a dedicated 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 career growth. We partner with leading manufacturing companies in Paw Paw, seeking experienced Validation Engineers to strengthen their teams.

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 Paw Paw 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, and PQ activities for new and modified manufacturing systems.
• Analyze data and generate comprehensive validation reports.
• Conduct risk assessments and develop mitigation strategies for manufacturing processes.
• Ensure compliance with cGMP, FDA regulations, and industry standards.
• Troubleshoot validation discrepancies and implement corrective actions.
• Collaborate with cross-functional teams on new product introductions and process improvements.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Proven experience with GxP regulations, FDA 21 CFR Part 11, Part 820, and relevant industry standards (e.g., ISO 13485).
• Demonstrated expertise in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of statistical methods for data analysis and validation.
• Experience with risk assessment tools and methodologies (e.g., FMEA).

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software validation in a manufacturing context (e.g., SCADA, DCS, PLCs).
• Certified Quality Engineer (CQE) or similar professional certification.
• Knowledge of cybersecurity principles as they apply to validated systems.
• Experience with risk management methodologies (e.g., FMEA, PHA) in a validation context.

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 Automation Engineer, Quality Assurance Engineer, QA Engineer, Validation Specialist, Validation Lead, Validation Manager, Compliance Engineer, Regulatory Affairs Engineer, GxP 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. The Pivot Group Network offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.