Senior Validation Engineer – GMP/Regulated Manufacturing

the-pivot-group-careers; Michigan; On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Network is partnering with Byron Center-based manufacturers to connect experienced Validation Engineers with current and future opportunities. This role focuses on validating equipment, processes, and software to ensure compliance and quality throughout the product lifecycle.

Candidates should have a Bachelor's in engineering or life sciences and 3+ years in regulated environments, with strong documentation skills and knowledge of GxP and FDA requirements.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years in validation within regulated manufacturing (medical device/pharma/biotech).
• Knowledge of GxP, FDA 21 CFR Part 11/Part 820, ISO 13485.
• Experience developing/ executing IQ, OQ, PQ for equipment, processes and software.
• Strong technical writing for validation documentation.

Responsibilities

• Develop, execute, and review validation protocols for equipment, processes, and software.
• Perform risk assessments and create validation plans for regulatory compliance.
• Analyze validation data, write reports, present findings to cross-functional teams.
• Investigate deviations and non-conformances in validation activities.
• Maintain master plans and schedules for timely validation completion.
• Collaborate with engineering/quality/production to integrate validation into product lifecycle.

Skills

GxP knowledge

FDA regulations knowledge

Validation protocol development

Education

Bachelor's degree in Engineering/Life Sciences or related

Tools

Minitab

JMP

PLC

SCADA

MES

Job description

The Pivot Group Network is partnering with Byron Center-based manufacturers to connect experienced Validation Engineers with current and future opportunities. This role focuses on validating equipment, processes, and software to ensure compliance and quality throughout the product lifecycle.

Candidates should have a Bachelor's in engineering or life sciences and 3+ years in regulated environments, with strong documentation skills and knowledge of GxP and FDA requirements.