Validation Engineer - Delta Township Area

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

Job summary

Validation Engineer role in Delta Township, MI with exposure to cGMP, FDA and ISO standards. You will design, execute, and document validation activities for equipment, processes and software within a manufacturing setting.

Collaborate with R&D, manufacturing and QA to ensure quality compliance and readiness for audits, while delivering clear reports and risk mitigations aligned with client needs.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• 3+ years of validation experience in regulated manufacturing (medical devices, pharma, biotech).
• Demonstrated expertise in developing and executing IQ/OQ/PQ validation protocols.
• Strong knowledge of cGMP and FDA regulations (21 CFR Part 11, 820) and ISO 13485.
• Proficiency in statistical methods and data analysis for validation activities.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for manufacturing systems.
• Analyze validation data and prepare comprehensive validation reports.
• Conduct risk assessments and mitigation strategies for validation activities.
• Ensure compliance with cGMP, FDA regulations, and internal quality standards.
• Participate in internal and external audits related to validation activities.
• Collaborate with cross-functional teams, including R&D, manufacturing, and QA.

Education

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

Tools

Python

R

Job description

Validation Engineer | Delta Township, MI

Salary Range: $80,000 - $120,000 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 Delta Township 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 collaborating with multiple companies in Delta Township seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your 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.
• Analyze validation data and prepare comprehensive validation reports.
• Conduct risk assessments and develop mitigation strategies for validation activities.
• Ensure compliance with cGMP, FDA regulations, and internal quality standards.
• Participate in internal and external audits related to validation activities.
• Collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance.

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).
• Demonstrated expertise in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 11, 820), and industry standards (e.g., ISO 13485).
• Proficiency in statistical methods and data analysis for validation activities.

Bonus Qualifications

• Experience with statistical process control (SPC) and design of experiments (DOE).
• Familiarity with Six Sigma or Lean manufacturing methodologies.
• Working knowledge of programming languages like Python or R for data analysis.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with risk management tools such as FMEAs.

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