Validation Engineer – Build Quality & Compliance

the-pivot-group-careers; Holt (MI); On-site; USD 75,000 - 114,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer in Holt, MI to develop and execute validation protocols for equipment, processes, and software in a regulated manufacturing setting. You will perform IQ/OQ/PQ activities for new and modified systems and author comprehensive validation reports.

Ideal candidates have a bachelor's degree in a technical field, 2+ years in validation within GMP environments, and strong knowledge of GxP (FDA/ISO) regulations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years experience in validation activities within a regulated manufacturing environment.
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with validation methodologies including IQ, OQ, PQ, process validation, and software validation.
• Proficiency in writing and executing validation protocols and reports.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified systems.
• Analyze validation data and author comprehensive validation reports.
• Investigate and resolve deviations and non-conformances during validation activities.
• Ensure all validation activities comply with cGMP, FDA, and internal quality standards.
• Maintain and update validation documentation throughout the system lifecycle.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing.

Skills

IQ/OQ/PQ validation

Validation protocols

Data analysis (SPC)

Education

Bachelor's degree in Engineering/Life Sciences

Tools

MiniTab

JMP

SCADA

DCS

PLCs

Job description

The Pivot Group Network is seeking a Validation Engineer in Holt, MI to develop and execute validation protocols for equipment, processes, and software in a regulated manufacturing setting. You will perform IQ/OQ/PQ activities for new and modified systems and author comprehensive validation reports.

Ideal candidates have a bachelor's degree in a technical field, 2+ years in validation within GMP environments, and strong knowledge of GxP (FDA/ISO) regulations.