Validation Engineer
ProKatchers
Job Title : VALIDATION ENGINEER
Location : Miami, FL 33196
Duration : 12 Months
Shift Details : Onsite
Specific Skills :
Quality Assurance/ ISO 13485 /IOQ/Process Validation/PQ/TMV/AQ/Certified Quality Engineer (CQE)
Job Description :
- Develop, write, and execute validation protocols, including IOQ and spreadsheet validations for Reagent Manufacturing processes.
- Perform and complete PQ, TMV, AQ, and other process validation activities in accordance with regulatory requirements.
- Develop, maintain, monitor, and audit Quality Management Systems (QMS), ensuring compliance with applicable regulations and industry standards.
- Support process validation deliverables, including systems automation, process improvements, procedures, and quality documentation.
- Ensure compliance with 21 CFR Part 820 and ISO 13485 requirements within the medical device manufacturing environment.
- Collaborate with senior QA and Process Validation teams to ensure validation effectiveness and regulatory compliance; utilize Microsoft Excel and programming knowledge to support validation activities.
Preferred Qualifications:
- Experience with PQ, TMV, AQ, NPSV, and GAMP 5 validations.
- ASQ Certified Quality Engineer (CQE) certification.
Vacancy posted 1 day ago
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