Job Title

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 dedicated Senior Validation Engineer (Documentation and Configuration of product) to join our team. The successful candidate will be responsible for ensuring compliance with health, safety, and environmental regulations. The EHS Technician will identify potential hazards, conduct safety inspections, ensure that employees follow safety protocols, and coordinate emergency procedures.KEY RESPONSABILITIES:Experience in Product Lifecycle Management (PLM) programs. Preferably ADAPTIV or similar.Demonstrate sufficient knowledge of Product Configuration: creation, modification, release, and obsolescence of bills of materials (BOM), part numbers, documents, specifications, work instructions, among others.Intermediate knowledge of engineering and Installation Qualification (IQ).Intermediate knowledge of engineering and Installation Qualification (OQ). Intermediate knowledge of engineering and Operational Qualification (PQ).Intermediate 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.Technical knowledge of running experiments during the pre-validation phase to determine optimal operational settings for maximum efficiency and product quality. Conduct other experiments as needed to identify sources of variation in manufacturing processes and reduce unnecessary variation and improve product quality. Demonstrate sufficient knowledge of validation skills, GMPs, Good Documentation Practices (GDP), and the ability to carry out change control, quality change requests, and other disciplinary protocols as needed.Must be familiar with and follow BEPC policies and procedures, as well as work activities within their area of responsibility. Complete all training in their area of responsibility within the assigned timeframe. Follow all company safety policies and safety precautions in the work area. Responsible for performing validations, including creating forms for calibration and preventive maintenance records.BASIC QUALIFICATIONS:Bachelor's degree in Engineering. 4+ years of experience in the manufacturing industry and/or 3 to 4 years of experience in the medical industry.Practical experience in PLM systems (ADAPTIV or similar), and solid knowledge in the creation, control and obsolescence of documents, BOMs and product specifications.Intermediate level of English (reading and writing) and intermediate English conversation skills. PREFERRED QUALIFICATIONS:Strong presentation skills before groups/clients. Intermediate knowledge of Six Sigma, DMAIC, and Kaizen. Intermediate knowledge of statistics.