BEPC has a Ciudad Juarez area OPEN POSITION for PM - Sr. Validation Engineer to join our fast-growing team of consultants! ON SITE IN CALIFORNIA for a 12 months contract.
WE DONT WORK WITH OTHER COMPANIES FOR C2C.
This role is responsible will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors.
Strong experience as Project Manager in medical devices companies is mandatory.
• 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)
• Support for the development of the production of new products.
• Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.
• Responsible for the analysis and development of manufacturing functions, capabilities and facilities necessary for the production of 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.
HAND ON MEDICAL DEVICES LINE TRANSFERS MANAGING ALL THE PROCESS.
Engineering Degree (master’s in science is a plus)
7 years of experience in medical industry
Good presentation skills before groups/clients.
Solid skills in developing Factorial Experiments (DOE).
Extensive knowledge in Lean.
Strong knowledge of Green or Black Six Sigma, DMAIC and Kaizen.
Strong knowledge of Project Management.
Extensive knowledge in statistics.
Advanced English level (reading, writing, and conversational)
Resident, US citizen or TN employee.
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