Validation Engineer 4
Validation Engineer 4
Posted on :
22-05-2025
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1 Vacancy
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Job Description
Job Description:
- Join a globally recognized leader in medical technology that specializes in lifesaving devices used in blood donation and plasma separation.
- This Validation & Quality Engineer 3 role supports a highimpact stable business unit working on a brandnew product thats entering an entirely new market for the company.
- Be part of a missiondriven team contributing to innovation and plays a critical role in healthcare worldwide.
Responsibilities:
- Lead validation projects including authoring and executing Validation Master Plans (VMP) Installation (IQ) Operational (OQ) and Performance Qualifications (PQ).
- Execute and document test method validation protocols conduct statistical analysis and ensure compliance with internal procedures.
- Support validation activities from approved suppliers ensuring records meet regulatory and corporate standards.
- Perform periodic reviews of automated equipment computerized systems and test instruments.
- Independently evaluate and adapt technical solutions for complex validation and quality engineering problems.
- Serve as project lead on highcomplexity projects overseeing total execution.
- Conduct root cause analyses and lead CAPA/NC resolution efforts.
- Collaborate across functions to maintain compliance with FDA ISO 13485 and GMP requirements.
Responsibilities:
- Minimum 8 years of validation and quality engineering experience in the medical device industry.
- Bachelors degree in Mechanical Electrical Biomedical Engineering or a relevant scientific field.
- Demonstrated experience with IQ/OQ/PQ process validation and test method validation.
- Working knowledge of FDA regulations ISO 13485 GMP and validation documentation.
- Proficient in risk management tools such as FMEA.
- Strong background in CAPA and NC processes including investigative and corrective actionsTechnical expertise in areas such as fluids engineering mechanical/chemical systems and cellular biology.
Employment Type
Full Time
Key Skills
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