Production Validation Engineer I (Hybrid, NJ)

Getinge Group; Wayne (NJ); Hybrid; USD 88,000 - 92,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Assistant

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge in Wayne, NJ is seeking an Engineer I, Production to review production documentation, address deficiencies, and perform equipment qualifications to support compliance and cost-saving improvements. The role reports to the Supervisor, Manufacturing Engineering and includes leading change notices, writing validation protocols, and ensuring adherence to quality systems and regulatory standards.

This is a hybrid role based in Wayne with some in-office days; compensation includes

Qualifications

• Bachelor of Science in Biomedical, Mechanical, Manufacturing Engineering or equivalent with 0-2 years of related experience.
• Understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
• Experience in a regulated environment preferred.
• Experience with Windchill software a plus.
• Formal training and/or experience in process validations/qualifications and statistics a plus.

Responsibilities

• Initiate Design Changes and Change Notices to document changes being implemented.
• Write and execute validation protocols, to demonstrate acceptability of a proposed change. Compile and analyze protocol test data.
• Review procedures and determine whether they are being followed. Implement changes as needed.
• Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
• Support efforts for complaint investigation compliance with FDA MDR, EUMDR, ASR, and applicable regulations and standards.
• Assess and implement solutions relating to corrective and preventive actions, calibration out of tolerances, non-conformances.

Skills

Technical ability

Communication skills

Organizational skills

Computer skills

Statistical analysis

Project management

Education

B.S. in Engineering

Tools

Windchill

Job description

Getinge in Wayne, NJ is seeking an Engineer I, Production to review production documentation, address deficiencies, and perform equipment qualifications to support compliance and cost-saving improvements. The role reports to the Supervisor, Manufacturing Engineering and includes leading change notices, writing validation protocols, and ensuring adherence to quality systems and regulatory standards.

This is a hybrid role based in Wayne with some in-office days; compensation includes