Validation Engineer
prokatchersMiami Springs (FL)
About the role
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.
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