Process Validation Engineer

Title: Process Validation Engineer/Quality Assurance Engineer

Location: Hebron, KY

Duration: 12+ months W2 contract with high possibility of extension based on performance and business needs

Job Description:

• The Quality Assurance Engineer is part of the Process Validation Group, specializing in all types of validation deliverables.
• The Quality Assurance Engineer is a key member of the PV team, reporting to the Senior Manager, Process Validation.
• You will collaborate with senior QA staff, taking responsibility for Process Validation Reagents within Reagent Manufacturing.

Key Responsibilities:

• Write and conduct IOQ and spreadsheet validations.
• Complete PQ, TMV, AQ validations.
• Develop, maintain, monitor, and audit the quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.

Essential Requirements:

• Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry.
• Familiarity with CFR 21 Part 820 and ISO 13485.
• Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.

Preferred Qualifications

It would be a plus if you also possess previous experience in:

• Knowledge of PQ, TMV, AQ, NPSV validations.
• Exposure to GAMP5 or similar regulations.
• ASQ Certified Quality Engineer (CQE) certification