Validation Engineer - Newaygo Area

the-pivot-group-careers; Michigan; On-site; USD 80,000 - 120,000; Full time

Job summary

The Pivot Group Network in Newaygo, MI is seeking a Validation Engineer to lead and enhance validation activities for equipment, processes, and software. This role supports cross-functional teams across R&D, Quality, and Manufacturing with a focus on regulatory compliance.

With 3+ years of validation experience in regulated manufacturing, you will develop validation plans and reports, analyze data, and drive continuous improvement of validation methodologies.

Qualifications

• Bachelor's degree in engineering or related science.
• 3+ years in validation activities within regulated manufacturing.
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, ISO 13485).
• Experience with IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis for process validation.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes and software.
• Perform risk assessments and generate validation plans for regulatory compliance.
• Analyze validation data, write validation reports, and present findings.
• Investigate deviations or non-conformances identified during validation.
• Collaborate with R&D, Quality, and Manufacturing to define validation strategies.
• Maintain validation documentation per internal procedures and external regulations.
• Support continuous improvement by optimizing validation processes and methodologies.

Skills

GxP knowledge

Statistical analysis

Validation lifecycle

Cross-functional teams

Regulatory compliance

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

SCADA

DCS

PLC programming

Job description

Validation Engineer | Newaygo, MI

Salary Range: $80,000 - $120,000 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 Newaygo 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 collaborate with manufacturing companies in the Newaygo region seeking Validation Engineers. These employers partner with us because they want real insight into candidates—not just resumes. By joining our network, you gain access to roles worth considering.

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 validation data, write comprehensive validation reports, and present findings to stakeholders.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to define validation strategies.
• Maintain validation documentation in accordance with internal procedures and external regulations.
• Support continuous improvement initiatives by optimizing validation processes and methodologies.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation lifecycle activities, including IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis tools for process validation and data analysis.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., SCADA, DCS, PLC programming).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Project management experience or certification (e.g., PMP).
• Experience with Computerized Maintenance Management Systems (CMMS) or Enterprise Asset Management (EAM) software.

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Validation Engineer, Equipment Validation Engineer, Process Validation Engineer, Cleaning Validation Engineer, Computer System Validation Engineer, Software Validation Engineer, Validation Specialist, Validation Lead, Validation Manager, Quality Engineer, QA Engineer, Regulatory Affairs Specialist, Compliance Engineer, Test Engineer, Verification Engineer, Automation Engineer, Pharmaceutical Validation Engineer, Biotech 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.