Validation Engineer - Caledonia Area

the-pivot-group-careers; Caledonia (MI); On-site; USD 67,000 - 112,000; Full time

Job summary

The Pivot Group Network in West Michigan recruits for a Validation Engineer based in Caledonia, MI. The position aims to lead validation activities for equipment, processes, and software in a regulated manufacturing setting.

Applicants should hold a Bachelor's degree in engineering or life sciences and have 3+ years in validation with GxP and FDA requirements (21 CFR Part 820, Part 211, Part 11). Strong analytical and cross-functional collaboration skills are essential.

Qualifications

• 3+ years of validation experience in a regulated manufacturing environment.
• Strong knowledge of GxP and FDA regulations.
• Experience developing, executing, and reviewing validation protocols and reports (IQ/OQ/PQ).

Responsibilities

• Develop, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation plans based on regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to ensure successful project execution and adherence to quality standards.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Maintain and update validation documentation to ensure compliance with cGMP, FDA, and other regulatory guidelines.
• Provide technical expertise and guidance on validation strategies and requirements to various departments.
• Participate in internal and external audits, providing necessary documentation and support.
• Develop and deliver training on validation principles and procedures to manufacturing and quality personnel.

Skills

Validation experience

GxP knowledge

FDA regulations

IQ/OQ/PQ experience

Statistical analysis

Education

Bachelor's degree in Engineering or Life Sciences

Tools

IQ/OQ/PQ protocols

Job description

Validation Engineer | Caledonia, MI

Salary Range: $73,000 - $112,000 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 Caledonia 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 partnering with organizations in Caledonia 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, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation plans based on regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to ensure successful project execution and adherence to quality standards.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Maintain and update validation documentation to ensure compliance with cGMP, FDA, and other regulatory guidelines.
• Provide technical expertise and guidance on validation strategies and requirements to various departments.
• Participate in internal and external audits, providing necessary documentation and support.
• Develop and deliver training on validation principles and procedures to manufacturing and quality personnel.

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).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and international standards (e.g., ISO 13485).
• Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical analysis tools and methodologies for validation activities.

Bonus Qualifications

• Additional certifications or training

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 Automation Engineer, Quality Assurance Engineer, QA Validation Engineer, Regulatory Affairs Specialist, Compliance Engineer, GxP 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.