Associate CQV Engineer
Company | Natera |
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Location | San Carlos, CA, USA |
Salary | $72000 – $90000 |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Entry Level/New Grad, Junior |
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Molecular Biology, or related field.
- 0–2 years of experience in CQV or regulated laboratory settings.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and basic data analysis tools.
- Strong attention to detail and ability to follow protocols meticulously.
- Excellent communication and teamwork skills.
Responsibilities
- Assist in the development and execution of IQ, OQ, and PQ protocols for laboratory equipment and automated systems.
- Conduct periodic calibrations, system verifications, and validation activities to support compliance with industry standards.
- Collaborate with cross-functional teams (e.g., R&D, QA, lab staff) to gather system requirements and maintain validation documentation.
- Draft, review, and update validation documentation, including protocols, work instructions, and summary reports.
- Perform data collection and fundamental analysis to support qualification efforts and report validation findings.
- Troubleshoot and support corrective actions for minor issues during equipment qualification activities.
- Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and internal safety protocols.
- Support periodic reviews of laboratory systems to ensure continued compliance and efficiency improvements.
- Assist with training new personnel on validation processes and best practices.
Preferred Qualifications
- This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
- Duties may require working outside normal working hours (evenings and weekends) at times.