MES Validation Engineer
hace 2 días
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 seeking a detail-oriented and analytical MES Validation Engineer – Configurator to join our team in the medical device industry. The ideal candidate will be responsible for configuring and validating Manufacturing Execution Systems (MES) to ensure compliance with industry standards and internal quality requirements.
Key responsabilities
Configure MES systems according to production and regulatory requirements. Validate MES functionalities through structured testing and documentation. Analyze data to support system optimization and troubleshooting. Collaborate with cross-functional teams including IT, Quality, and Manufacturing.
Technical knowledge of engineering and Installation Qualification (IQ). Technical knowledge of engineering and Operational Qualification (OQ). Technical knowledge of validation activities and ensuring they are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP), and support activities related to any associated deviations. Experience in Product Lifecycle Management (PLM) programs.
Preferably ADAPTIV or similar.
Qualifications
Bachelor's degree in Engineering (Industrial, Systems, Computer, or related fields). 2 to 3 years of experience working with MES systems. Strong understanding of programming logic. Proficiency in SQL configuration language. Experience in data analysis and interpretation.
Excellent problem-solving skills and attention to detail. Ability to work in a regulated environment with a focus on quality and compliance. Upper-intermediate level of English (reading and writing) and intermediate English conversation skills.
Preferred qualifications
Previous experience in the medical device or pharmaceutical industry. Familiarity with GMP, FDA, or ISO standards.
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