Validation Engineer - Muskegon Area

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

Job summary

The Pivot Group Network is seeking a Validation Engineer in Muskegon, MI to lead and optimize validation activities across equipment, processes and software. The successful candidate will design and execute IQ/OQ/PQ protocols, assess risk, and ensure adherence to FDA, ISO, and internal quality standards.

Applicants should have a Bachelor's degree in a relevant field and 3+ years in regulated manufacturing validation, with strong documentation and data analysis skills for reporting and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of validation experience in regulated manufacturing (medical device, pharma, biotech).
• Experience authoring/executing IQ, OQ, PQ protocols and reports for equipment, processes and software.
• Strong knowledge of cGMP and FDA regulations (21 CFR Part 820, Part 210/211, Part 11) 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, generate reports, and present findings to stakeholders.
• Ensure compliance with regulatory requirements (FDA, ISO) and internal quality standards.
• Investigate and resolve deviations and non-conformances related to validated systems.
• Maintain validation master plans and documentation throughout the lifecycle.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing) on validation efforts.

Skills

Regulatory knowledge

Statistical methods

Risk assessment

Documentation & reporting

Education

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

Tools

Minitab

JMP

SCADA

PLC/automation software

Job description

Validation Engineer | Muskegon, 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 Muskegon 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 are collaborating with manufacturing firms in Muskegon that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

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, generate reports, and present findings to stakeholders.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Investigate and resolve deviations and non-conformances related to validated systems.
• Maintain validation master plans and associated documentation throughout the lifecycle.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) on validation efforts.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Proven experience authoring and executing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 820, Part 210/211, Part 11), and industry standards (e.g., ISO 13485).
• Experience with statistical methods for validation and process control.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software used in manufacturing (e.g., SCADA, DCS, PLCs).
• Project management certification (e.g., PMP, CAPM) or demonstrated experience leading validation projects.
• Advanced degree in a relevant scientific or engineering discipline.
• Lean Six Sigma Green or Black Belt certification.

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, Validation Specialist, Validation Lead, Quality Engineer (Validation), QA 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.