Provides specialized engineering solutions & IT project management for Fortune 500 life science and tech firms.
Provide technical engineering support for validations, write and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.
Support in the execution of experiments during the pre-validation phase.
Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.
Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).
Provide technical engineering support for validations, write and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.
Intermediate English level (reading and writing) with intermediate conversation skills.
Engineering Degree
Intermediate knowledge in statistics.
Good presentation skills before groups/clients.
Basic knowledge of Six Sigma, DMAIC and Kaizen.
Demonstrate sufficient knowledge in basic validation skills, GMP, Good Documentation Practices (GDP).
2 - 4 years of experience in the manufacturing industry and/or 2 – 3 years of experience in medical industry