Validation Engineer - Walker Area

the-pivot-group-careers; Walker (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network is partnering with Walker, MI-based manufacturers to identify a Validation Engineer. Salary ranges from $81,000 to $121,000 depending on experience, with comprehensive benefits and growth opportunities.

As a Validation Engineer, you will develop and execute IQ/OQ/PQ protocols for equipment and processes, perform risk assessments, generate validation plans and reports, and collaborate with R&D, Quality, and Manufacturing to drive compliant solutions.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of validation experience in a regulated manufacturing environment.
• Strong understanding of GxP regulations and industry standards (FDA 21 CFR Part 820, ISO 13485).
• Experience developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing and communication skills for validation documentation.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment and processes.
• Perform risk assessments and generate validation plans for new and modified systems.
• Analyze data and generate validation reports summarizing results and conclusions.
• Investigate deviations and non-conformances during validation activities, implementing corrective actions.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to ensure successful project execution.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Provide technical expertise and guidance on validation principles and best practices.

Skills

GxP regulations

Technical writing

Cross-functional collaboration

IQ/OQ/PQ protocol development

Education

Bachelor's degree in engineering or related scientific discipline

Tools

CSV experience

Job description

Validation Engineer | Walker, MI

Salary Range: $81,000 - $121,000 depending on experience

Are you a forward-thinking 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 in the manufacturing community. We partner with companies in Walker seeking skilled 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 partnering with organizations in Walker 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 (IQ, OQ, PQ) for manufacturing equipment and processes.
• Perform risk assessments and generate validation plans for new and modified systems.
• Analyze data and generate validation reports summarizing results and conclusions.
• Investigate deviations and non-conformances during validation activities, implementing corrective actions.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to ensure successful project execution.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Provide technical expertise and guidance on validation principles and best 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 devices, pharmaceuticals).
• Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing and communication skills for authoring and reviewing validation documentation.

Bonus Qualifications

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with GAMP 5 guidelines.
• Knowledge of statistical methods for data analysis and sampling.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with risk management tools and methodologies (e.g., FMEA, PHA).

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Qualification Engineer, Validation Specialist, Quality Validation Engineer, Senior Validation Engineer, Lead 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.