Packaging Validation Engineer III (Medical Industry)

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe. We are looking for a Packaging Validation Engineer III to lead and implement changes in the packaging processes, for straight and square product lines, to validate equipment that makes up the process, including the sterile barrier system and the primary, secondary, and protective packaging. packaging. In this position, the day will include writing and executing packaging validation protocols, conducting change management assessments, creating, and executing engineering change orders, conducting engineering studies, and developing Designs of Experiments (DOE). In addition, lead studies, verification runs and the preparation of associated reports. KEY RESPONSABILITIES: Lead and implement changes in the packaging components that make up the sterile barrier system, as well as protective packaging. Write/execute packaging validation protocols (IQ, OQ, TMV,) and their associated completion reports. Write/execute change management/change control assessments (e.g. validation, process, etc.). Create/execute engineering change orders. Create/execute engineering studies, verification runs and their corresponding completion reports. BASIC QUALIFICATIONS: Bachelor's degree 2 years of experience in the manufacturing industry. 3 years of experience in the Medical Device industry. Creation of IQ/OQ/PQ Protocols & Reports. ISO-13485 and ISO-11607 21 CFR Part. 820 Packaging Experience in medical industry Knowledge in packaging tests for lab equipment Advanced level of English , reading, writing and conversational (MUST). Willing to relocate to Santa Clara, California (MUST) TN Visa sponsorship available.

Location: Tijuana, Baja California, MX

Posted Date: 8/26/2025