What are the responsibilities and job description for the Quality Assurance Engineer Process Validation in Hebron, KY position at Select Source International?
Job Title Quality Assurance Engineer (Process Validation Expert Level)
Job Location Type In Person
Location Hebron, KY 41048
Job Type 12-Month Contract (Possible Temp-to-Hire)
Shift Schedule 1st Shift | Standard Business Hours
About The Role
We are seeking an experienced Quality Assurance Engineer to join the Process Validation (PV) team supporting reagent manufacturing operations.
This role is ideal for a validation-focused QA professional with strong experience in process validation, quality systems, and regulatory compliance within the medical device industry. You will play a key role in ensuring validation deliverables and quality systems meet stringent regulatory standards while supporting manufacturing and process improvements.
Key Responsibilities
Job Location Type In Person
Location Hebron, KY 41048
Job Type 12-Month Contract (Possible Temp-to-Hire)
Shift Schedule 1st Shift | Standard Business Hours
About The Role
We are seeking an experienced Quality Assurance Engineer to join the Process Validation (PV) team supporting reagent manufacturing operations.
This role is ideal for a validation-focused QA professional with strong experience in process validation, quality systems, and regulatory compliance within the medical device industry. You will play a key role in ensuring validation deliverables and quality systems meet stringent regulatory standards while supporting manufacturing and process improvements.
Key Responsibilities
- Author and execute validation activities including:
- IOQ (Installation, Operational, Qualification)
- Spreadsheet validation
- PQ (Performance Qualification)
- TMV (Test Method Validation)
- AQ (Analytical Qualification)
- Develop, maintain, and audit Quality Management System (QMS) processes and documentation
- Monitor validation protocols and ensure compliance with internal and external standards
- Support automation validation and system/process validation activities
- Collaborate with senior QA staff and cross-functional teams within manufacturing and engineering
- Ensure compliance with:
- FDA regulations (21 CFR Part 820)
- ISO 13485 standards
- Identify gaps and drive continuous improvement in validation and quality processes
- Bachelor s degree in Engineering (Mechanical, Electrical, Chemical, Bioengineering, or related field)
- 5 years of experience in the medical device industry
- Strong hands-on experience with:
- Process validation
- Validation protocol development and execution
- Working knowledge of:
- 21 CFR Part 820
- ISO 13485
- Proficiency in Microsoft Excel
- Basic understanding of computer systems, programming, or system validation
- Experience with:
- PQ, TMV, AQ, NPSV validations
- Familiarity with GAMP 5 or similar computerized system validation frameworks
- ASQ Certified Quality Engineer (CQE) certification
- Experience supporting reagent manufacturing or similar regulated production environments
Salary : $45 - $47