Validation Engineer — Drive Compliance in Manufacturing

the-pivot-group-careers; Plainwell (MI); On-site; USD 79,000 - 119,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer in Plainwell, MI to develop, execute, and manage validation activities for equipment, processes, and software. You will work with engineering, quality, and production teams to ensure compliance with GxP and FDA requirements.

Ideal candidates have 3+ years in regulated manufacturing validation, experience with IQ/OQ/PQ, and strong statistical analysis skills.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of validation experience in regulated manufacturing (medical device, pharmaceutical, biotech).
• Strong understanding of GxP, FDA regulations (21 CFR Part 820, Part 211, Part 11), and ISO 13485.
• Proven experience in developing, executing, and reviewing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and tools for data analysis and validation.

Responsibilities

• Develop, execute, and review validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze validation data, generate reports, and present findings to cross-functional teams.
• Investigate and resolve deviations, non-conformances, and OOS results during validation activities.
• Collaborate with engineering, quality, and production teams to integrate validation requirements into systems.
• Maintain validation master plans, schedules, and documentation in an organized, compliant manner.
• Support internal and external audits by providing validation documentation and expertise.

Skills

Validation experience

Statistical analysis

GxP knowledge

FDA regulations

Education

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

Tools

Minitab

JMP

Job description

The Pivot Group Network is seeking a Validation Engineer in Plainwell, MI to develop, execute, and manage validation activities for equipment, processes, and software. You will work with engineering, quality, and production teams to ensure compliance with GxP and FDA requirements.

Ideal candidates have 3+ years in regulated manufacturing validation, experience with IQ/OQ/PQ, and strong statistical analysis skills.