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 has a ciudad juarez area open position for senior validation engineer to join our fast-growing team of consultants!
key responsabilities:
* 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.
* provide technical engineering support for validations, write, and execute total maintenance validation (tmv) protocols.
* provide technical engineering support for validations, write, and execute sat (factory acceptance testing) validation protocols, and provide data to write completion reports for assigned validations.
* responsible for running experiments during the pre-validation phase, run 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.
basic qualifications:
* engineering degree (master's in science is a plus)
* 4 - 6 years of experience in the manufacturing industry and/or 5 – 6 years of experience in medical industry
* good presentation skills before groups/clients.
* solid skills in developing factorial experiments (doe).
* extensive knowledge in lean.
* intermediate knowledge in six sigma, dmaic and kaizen.
* intermediate knowledge in project management.
* extensive knowledge in statistics.
* advanced english level (reading, writing and conversational)