Senior Validation Engineer - Manufacturing Excellence

Medix™; Lake Geneva (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

Medix is seeking a seasoned Validation Engineer to lead manufacturing process validation, equipment qualification, and data integrity on the Lake Geneva production floor.

The role requires 6+ years in regulated manufacturing, strong knowledge of IQ/OQ/PQ, DOE, MSA, SPC, and experience with cGMP, ISO 13485, 21 CFR 820. You will collaborate across Manufacturing, Quality, and Engineering to ensure compliant, efficient operations. On-site role with potential mentorship of engineers and technicians.

Qualifications

• 6+ years of validation experience in regulated manufacturing (medical device/pharma/combination products).
• Strong experience with IQ/OQ/PQ and validation lifecycle activities.
• Knowledge of cGMP, ISO 13485, 21 CFR 820, and Part 11; familiarity with GAMP 5 and risk-based validation preferred.

Responsibilities

• Lead validation activities for manufacturing processes, equipment, and supporting systems.
• Develop and execute validation documentation (Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols and reports).
• Coordinate shop-floor execution of validation protocols (resources, sampling, instrumentation, testing).
• Establish and evaluate critical process parameters, control limits, and process capability using DOE, MSA, SPC, and capability analysis.

Skills

Validation

Cross-functional collaboration

Statistical methods

Documentation

Data integrity

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

Medix is seeking a seasoned Validation Engineer to lead manufacturing process validation, equipment qualification, and data integrity on the Lake Geneva production floor.

The role requires 6+ years in regulated manufacturing, strong knowledge of IQ/OQ/PQ, DOE, MSA, SPC, and experience with cGMP, ISO 13485, 21 CFR 820. You will collaborate across Manufacturing, Quality, and Engineering to ensure compliant, efficient operations. On-site role with potential mentorship of engineers and technicians.