Validation Engineer - Portage Area

the-pivot-group-careers; Portage (MI); On-site; USD 72,000 - 111,000; Full time

Job summary

The Pivot Group Network is partnering with Portage-area manufacturers to hire a Validation Engineer. The role focuses on IQ/OQ/PQ, risk assessments, and regulatory compliance within a manufacturing environment.

The successful candidate will lead validation activities for equipment, processes, and software, collaborate with R&D, manufacturing, and QA, and ensure adherence to FDA and ISO standards. Salary ranges from $72,000 to $111,000 plus benefits.

Qualifications

• Bachelor's degree in engineering or related science required.
• 3+ years in validation within regulated manufacturing (medical devices/pharma).
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• Conduct risk assessments and develop mitigation strategies for validation activities.
• Analyze validation data and prepare comprehensive reports summarizing results and conclusions.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Collaborate with cross-functional teams including R&D, manufacturing, and QA.
• Investigate and resolve deviations and non-conformances identified during validation.

Skills

GxP knowledge

Validation lifecycle experience

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering or related science

Tools

Minitab

JMP

PLC/SCADA

Job description

Validation Engineer | Portage, MI

Salary Range:

$72,000 - $111,000 depending on experience

Are you a meticulous 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 growth. We are collaborating with companies in Portage 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 partnering with organizations in Portage 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 for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• Conduct risk assessments and develop mitigation strategies for validation activities.
• Analyze validation data and prepare comprehensive reports summarizing results and conclusions.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• Investigate and resolve deviations and non-conformances identified during validation.

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 with validation lifecycle activities including IQ, OQ, PQ protocols and reports for equipment, processes, and software.
• Demonstrated ability to author and execute validation documentation effectively.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLCs, SCADA, MES).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Demonstrated ability to mentor junior engineers or lead small project teams.
• Experience with specific industry regulations beyond general GMP (e.g., ISO 13485 for medical devices, 21 CFR Part 11 for electronic records).

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 Engineer (Validation), QA Validation Engineer, Validation Specialist, Validation Lead, Validation Manager, Quality Engineer (Validation), Compliance Engineer (Validation

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.