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DescripciónDescription
We are seeking a highly skilled Validation Engineer to join our growing team to support Product/Equipment Transfer and New Product Introduction (NPI) activities at a leading Medical Devices company. This role is critical in ensuring that all product, process, and equipment validations are executed in compliance with regulatory standards and internal quality requirements to support the seamless transfer of new products and technology into production.
The ideal candidate will have a strong background in medical device manufacturing, as well as experience in validation activities related to equipment, processes, and systems. You will work cross-functionally with Process Development (PD), manufacturing, quality assurance, and regulatory teams to ensure the successful introduction and transfer of new products.
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Requisitos Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 3+ years of experience in validation engineering, specifically within the medical device or regulated industry.
- Experience with product/equipment transfer, new product introduction, and manufacturing process/equipment validation.
- Familiarity with regulatory requirements, including FDA 21 CFR Part 820, and other relevant standards.
- Proficiency in developing and executing IQ, OQ, PQ protocols and reports.
- Strong understanding of Good Manufacturing Practices (GMP) and risk management principles.
- Excellent problem-solving skills and the ability to analyze complex validation data.
- Strong written and verbal communication skills with the ability to create clear documentation.
- Ability to work effectively within cross-functional teams and with external vendors or suppliers.
- Knowledge of statistical analysis tools for validation testing (e.g., Minitab, or similar tools) is a plus.
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