Senior Validation Specialist
hace 1 mes
BEP Consulting is a leading expert in business excellence and professional consulting. We are currently seeking an experienced Senior Validation Specialist to join our team.
Job DescriptionWe are looking for a skilled validation engineer with extensive experience in IQ, OQ, PQ, MPV protocols and medical devices industry. As a Senior Validation Specialist, you will be responsible for acting as Subject Matter Expert (SME) for business excellence tools such as line balancing, standard work, 5s, etc.
Your key responsibilities will include:
- Analysis and investigation of line balancing, time, and motion studies, standard work, among others, to ensure that the production line is balanced and complies with the required production schedule.
- Create/Execute engineering change orders.
- Write/Approve changes related to manufacturing documentation and/or systems such as manufacturing work instruction, BOM, Router.
- Create/Update Operating Standard Overview.
- Write/Execute Process Validation Protocols (IQ, OQ, PQ, TMV) and their associated completion reports.
The ideal candidate should have a strong understanding of validation processes and regulations, as well as excellent analytical and problem-solving skills.
Required Skills and QualificationsTo be successful in this role, you will need:
- Advanced English level.
- Bachelor degree.
We offer a comprehensive benefits package, including:
- Health insurance.
The estimated annual salary for this position is $70,000 - $90,000 depending on experience.
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