02 oct
|
BEPC Inc. - Business Excellence Professional Consulting
|
Ciudad Juárez
02 oct
BEPC Inc. - Business Excellence Professional Consulting
Ciudad Juárez
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.
BEPC Inc. is seeking a Junior MES Software Validation Engineer to support software validation activities within regulated manufacturing environments. This role is designed for an early-career professional with technical knowledge of software validation and hands-on exposure to Manufacturing Execution Systems (MES). The position will work under the guidance of senior engineers and cross-functional teams, supporting validation documentation, testing activities, system changes, and compliance with CSV/SDLC and quality requirements.
KEY RESPONSIBILITIES:
- Support the execution of software validation activities in accordance with CSV and SDLC requirements.
- Assist in the preparation, execution, and maintenance of validation documentation, including validation plans, protocols, test scripts, and reports.
- Support MES (Manufacturing Execution System) validation and system-related activities within manufacturing environments.
- Assist with the creation and maintenance of Traceability Matrices (TM), UAT documentation, Design Specifications, and Hypercare Transition Plans (HCTP).
- Support the creation, execution, and completion of CP, CSCA, Test Protocols, and Test Reports.
- Assist with installation scripts and documented system implementation activities.
- Use JIRA to document validation activities,
track assigned tasks, issues, and project progress.
- Assist in investigating and documenting software or system issues identified during testing and validation.
- Collaborate with Engineering, Quality, Manufacturing, IT, and other cross-functional teams during MES implementation and validation activities.
- Follow established procedures, quality standards, and regulatory requirements applicable to software validation.
- Prepare clear and accurate technical documentation in English and communicate effectively with local and integral teams.
BASIC QUALIFICATIONS:
- Bachelor's degree, Associate degree, technical degree, or equivalent education in Computer Science, Software, IT, Engineering, Automation, Mechatronics, or a related technical field.
- 1–2 years of experience in software validation, MES, manufacturing systems, IT systems, automation, quality, or a related technical environment.
- Hands-on experience or working knowledge of MES (Manufacturing Execution Systems) is strongly preferred.
- Basic knowledge of CSV and/or SDLC concepts.
- Exposure to software testing, validation documentation, test protocols, or regulated documentation.
- Experience in medical device, pharmaceutical, life sciences, or another regulated manufacturing environment is preferred.
- Familiarity with JIRA or similar issue/task management tools is desirable.
- Good analytical, organizational, and problem-solving skills.
- Intermediate to advanced English proficiency, with the ability to understand technical documentation and communicate in a professional environment.
📌 Jr. MES Software Validation Engineer (Medical Industry) (Ciudad Juárez)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ciudad Juárez