Validation Engineer - Whitehall Area

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

Job summary

The Pivot Group Network is assisting West Michigan manufacturers in Whitehall to hire a Validation Engineer. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software, and support audits while ensuring regulatory compliance.

Ideal candidates bring 3+ years in regulated validation, a strong grasp of GxP and FDA/ISO standards, and a proven ability to analyze data and write conclusive validation reports.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years experience in validation activities within a regulated manufacturing environment.
• Demonstrated understanding of GxP, FDA regulations, ISO 13485 and related standards.
• Proven experience in developing, executing, and reviewing validation protocols and reports.
• Strong analytical and problem-solving skills with the ability to interpret complex data.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data and write comprehensive validation reports summarizing results and conclusions.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Collaborate with cross-functional teams to ensure successful validation outcomes.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Support internal and external audits by providing validation documentation and expertise.

Skills

GxP knowledge

Analytical thinking

Cross-functional collaboration

Regulatory interpretation

Education

Bachelor's degree in Engineering/Life Sciences or related

Tools

IQ/OQ/PQ protocols

CSV / validation documents

Job description

Validation Engineer | Whitehall, MI

Salary Range: $77,000 - $117,000 depending on experience

Are you ready to take on a challenging and rewarding opportunity in {{role_field}}? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to building meaningful connections in manufacturing. We partner with leading companies in Whitehall seeking 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 Whitehall 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 equipment, processes, and software.


• Perform risk assessments and generate validation plans.


• Analyze data and write comprehensive validation reports summarizing results and conclusions.


• Investigate and resolve deviations or non-conformances identified during validation activities.


• Collaborate with cross-functional teams (e.g., Quality, Engineering, Production) to ensure successful validation outcomes.


• Maintain validation documentation in accordance with regulatory requirements and internal procedures.


• Support internal and external audits by providing validation documentation and expertise.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.


• 3+ years experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotechnology).


• Demonstrated understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), ISO 13485, and other relevant industry standards.


• Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).


• Strong analytical and problem-solving skills with the ability to interpret complex data and make sound technical decisions.

Bonus Qualifications

• Additional certifications or training

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Quality Validation Engineer, Senior Validation Engineer, Principal 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.