Process Validation Engineer

Job Description

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.
• In this role, you will have the opportunity to:
• Write and conduct IOQ and spreadsheet validations.
• Complete PQ, TMV, AQ validations.
• Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.

The essential requirements of the job include:

• 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 ISO13485.
• Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.
• 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).