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.

at bepc inc., we are looking for a staff software validation engineer (csv) with deep expertise in end-to-end validation strategies, including process, equipment, computer systems, and maintenance validations. This role will lead doe development, lean six sigma initiatives, and project-level execution, while collaborating closely with operations, design, and engineering teams to ensure products meet regulatory, quality, and design requirements.

key responsibilities:

- responsible for leading and ensuring on-time execution of continuous improvement workstream #2 active projects as per commitment and plan.
- execute and generate moderate to high complex validation documentation.
- responsible for communicating and keeping track of the activities at the dtx core team, site leadership, business leadership stakeholders.
- responsible of updating and keeping track of the project's metrics, weekly updates and site dashboards (po tracker, project timelines, validation documentation tracker, risk register and kpi tracker).
- provide training sessions for team members and stakeholders on validation processes and tools.
- create and submit change projects & change orders (cos) ensuring proper documentation and approval processes are followed.
- collaborate with team members to gather requirements and feedback for validation of documentation and training materials.
- monitor and report on the status of validation activities and change orders to the project lead, site leadership and business leadership stakeholders.
- provide technical engineering support for validations, write, and execute installation qualification (iq) protocols,



and provide data to write completion reports for assigned validations.
- provide technical engineering support for validations, write, and execute operational qualification (oq) protocols, and provide data to write completion reports for assigned validations.
- provide technical engineering support for validations, write, and execute performance qualification (pq) protocols, and provide data to write completion reports for assigned validations.
- provide technical engineering support for validations, write, and execute computer systems validation (csv) protocols.
- responsible for running experiments during the pre-validation phase, running other experiments as needed.
- ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and good manufacturing practices (gmp).
- demonstrate sufficient knowledge in validation skills, gmp, good documentation practices (gdp).
- responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.
- support for the development of the production of new products.
- responsible for the analysis and development of manufacturing functions, capabilities and facilities necessary to produce the client's product.
- work with the operations and design team to verify and validate that the product under development meets regulatory and design requirements.

qualifications:

- engineering degree (master's in science is a plus)
- 6 – 9 years of experience in medical industry
- expert with lims or expert in connecting equipment's to lims software
- expert with software validation - should be able to draft, approve software validation documents - like urs, test protocol, computer specifications etc.
- expert with working/collaborating cross functional departments, multiple suppliers.
- expert with ms project, project management - be able to manage/track action plans for multiple equipment validation
- good presentation skills before groups/clients.
- solid skills in developing factorial experiments (doe).
- bilingual

📌 Ingeniero de validacion staff it (lims) (México)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 México