Validation Engineer

Prokatchers LLC; Miami (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Prokatchers LLC seeks a Quality Assurance professional with CQE certification to lead validation activities across IOQ, PQ, TMV, and AQ in a medical device manufacturing setting. The role emphasizes regulatory compliance with 21 CFR Part 820 and ISO 13485, along with QMS oversight.

You will collaborate with senior QA teams, develop validation protocols, and support system automation and documentation using Excel and programming skills.

Qualifications

• Experience with PQ, TMV, AQ, NPSV, and GAMP 5 validations.
• ASQ Certified Quality Engineer (CQE) certification.

Responsibilities

• 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 per regulatory requirements.
• Develop and maintain Quality Management Systems (QMS) ensuring compliance with regulations and standards.
• Support validation deliverables, including systems automation, procedures, and quality documentation.
• Ensure compliance with 21 CFR Part 820 and ISO 13485 in the medical device manufacturing environment.
• Collaborate with senior QA and Process Validation teams; utilize Excel and programming knowledge to support validation.

Skills

Programming knowledge

Education

ASQ CQE certification

Tools

GAMP 5

PQ

TMV

AQ

NPSV

Microsoft Excel

Job description

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.