MUST HAVE EXPERIENCE IN THE MEDICAL DEVICE INDUSTRY, VALIDATION PROTOCOLS IQ, OQ, PQ
KEY RESPONSIBILITIES:
- 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. Support in the execution of experiments during the pre-validation phase. 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 basic 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 2 - 4 years of experience in the manufacturing industry and/or 2 – 3 years of experience in medical industry Good presentation skills before groups/clients. Intermediate knowledge of statistics. Basic knowledge of Six Sigma, DMAIC and Kaizen. Intermediate English level (reading and writing) with intermediate conversation skills.
MXOPS
Job Type: Full-time
Pay: $100.00 - $200.00 per month
Work Location: In person