Senior Validation Engineer — GMP & Process Improvement

the-pivot-group-careers; Michigan; On-site; USD 80,000 - 120,000; Full time

Job summary

The Pivot Group Network in Newaygo, MI is seeking a Validation Engineer to lead and enhance validation activities for equipment, processes, and software. This role supports cross-functional teams across R&D, Quality, and Manufacturing with a focus on regulatory compliance.

With 3+ years of validation experience in regulated manufacturing, you will develop validation plans and reports, analyze data, and drive continuous improvement of validation methodologies.

Qualifications

• Bachelor's degree in engineering or related science.
• 3+ years in validation activities within regulated manufacturing.
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, ISO 13485).
• Experience with IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis for process validation.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes and software.
• Perform risk assessments and generate validation plans for regulatory compliance.
• Analyze validation data, write validation reports, and present findings.
• Investigate deviations or non-conformances identified during validation.
• Collaborate with R&D, Quality, and Manufacturing to define validation strategies.
• Maintain validation documentation per internal procedures and external regulations.
• Support continuous improvement by optimizing validation processes and methodologies.

Skills

GxP knowledge

Statistical analysis

Validation lifecycle

Cross-functional teams

Regulatory compliance

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

SCADA

DCS

PLC programming

Job description

The Pivot Group Network in Newaygo, MI is seeking a Validation Engineer to lead and enhance validation activities for equipment, processes, and software. This role supports cross-functional teams across R&D, Quality, and Manufacturing with a focus on regulatory compliance.

With 3+ years of validation experience in regulated manufacturing, you will develop validation plans and reports, analyze data, and drive continuous improvement of validation methodologies.