Quality Assurance Engineer Process Validation Hebron, KY
Job in
Hebron Estates, Bullitt County, Kentucky, USA
Listed on 2026-02-17
Listing for:
Jobs via Dice
Contract
position Listed on 2026-02-17
Job specializations:
-
Engineering
Quality Engineering, QA Specialist / Manager -
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager, Quality Control / Manager
Job Description & How to Apply Below
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Select Source International, is seeking the following. Apply via Dice today!
Job title Quality Assurance Engineer Process Validation
Job location type In person
Location Hebron, KY 41048
Job type 12 months contract with possible extension
Shift Schedule 1st Shift
Position OverviewWe are seeking an experienced Quality Assurance Engineer to join the Process Validation (PV) Group
, supporting validation deliverables within reagent manufacturing. This role reports to the Senior Manager, Process Validation and partners closely with cross‑functional quality and manufacturing teams to ensure compliance with regulatory and quality standards.
- Author and execute IOQ protocols and spreadsheet validations.
- Perform PQ, TMV, and AQ validations across process validation programs.
- Develop, maintain, monitor, and audit Quality Management System (QMS) documentation, protocols, and procedures.
- Ensure validation processes, automation systems, and manufacturing procedures meet regulatory and internal compliance requirements.
- Collaborate with QA leadership and technical stakeholders to support validation initiatives and continuous process improvements.
- Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Bioengineering, or related field).
- 5+ years of experience in the medical device industry.
- Strong knowledge of 21 CFR Part 820 and ISO 13485 standards.
- Advanced proficiency in Microsoft Excel and working knowledge of computer programming/systems.
- Experience with PQ, TMV, AQ, and NPSV validations.
- Familiarity with GAMP 5 or equivalent validation frameworks.
- ASQ Certified Quality Engineer (CQE) certification.
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