Senior Validation Engineer - 171296

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

Key Responsibilities

• Lead validation activities for manufacturing processes, equipment, and supporting systems.
• Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols and reports.
• Coordinate shop-floor execution of validation protocols, including resources, sampling, instrumentation, and testing.
• Establish and evaluate critical process parameters, control limits, and process capability using DOE, MSA, SPC, and capability analysis.
• Analyze manufacturing and validation data to identify trends and opportunities for improvement.
• Lead root cause investigations, CAPA activities, and process improvement initiatives.
• Support equipment qualifications, process changes, equipment transfers, and engineering changes while maintaining the validated state.
• Partner with Manufacturing, Quality, Engineering, and other cross-functional teams on validation and process improvement activities.
• Support improvements to quality systems, procedures, work instructions, and validation workflows.
• Ensure appropriate data integrity and documentation practices within computerized systems.
• Provide technical guidance and mentorship to engineers and technicians on validation practices, documentation, and statistical methods.

Qualifications

• Bachelor's degree in Engineering, such as Mechanical, Manufacturing, Industrial, Biomedical, or a related field.
• 6+ years of validation experience within a regulated manufacturing environment such as medical device, pharmaceutical, or 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 is preferred.
• Experience developing sampling strategies, acceptance criteria, and validation test methods.
• Strong understanding of DOE, MSA/Gage R&R, SPC, and process capability analysis.
• Experience using Minitab or similar statistical software.
• Strong technical writing, documentation, and data integrity skills.
• Experience with process/equipment qualifications, automated manufacturing, or cleanroom environments is preferred.
• Strong communication skills with the ability to work effectively across cross-functional teams.

Work Environment:

This is an on-site position supporting manufacturing and validation activities directly on the production floor.