Regulatory Compliance Engineer

hace 5 días


Carolina, Carolina, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

Job Overview
Biopharma Consulting Jad Group is seeking a highly experienced Validation Engineer to play a pivotal role in our operations. This position involves overseeing the validation processes for our pharmaceutical and biopharmaceutical products, ensuring compliance with industry regulations and standards.

Responsibilities:
· Commission and validate manufacturing equipment, utilities and facilities using Kneat.
· Develop design documents such as traceability matrices, user requirements and impact assessments associated to the systems within the scope of the project.
· Work closely with cross-functional teams to ensure seamless execution of validation activities.
· Identify areas for process improvement and implement changes as necessary.

Requirements:
· Bachelor's degree in Engineering, Life Sciences or a related field.
· 5+ years of experience in validation within the pharmaceutical or biotechnology industries.
· Strong knowledge of cGMP, GLP and GxP regulations.
· Excellent problem-solving skills and attention to detail.



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