Senior Validation Engineer – cGMP & FDA Compliance

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 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.