C&Q Engineer
Job Summary:
We are seeking a highly skilled and experienced C&Q Engineer to join our clients team. The successful candidate will be responsible for the generation, execution, and approval of qualification documents for direct impact systems (such as facilities, utilities, and equipment) and the creation of commissioning test documents for non-direct impact systems. This position requires strong technical expertise and a proactive approach in ensuring the systems and processes meet the highest standards of regulatory compliance.
Key Responsibilities:
1. Develop and approve qualification documents for direct impact systems including facility, utility, and equipment.
2. Create and review commissioning test documents for non-direct systems.
3. Conduct qualification protocols, including installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ), ensuring compliance with applicable standards and regulations.
4. Lead commissioning activities, ensuring that systems are designed, installed, and validated per cGMP guidelines.
5. Coordinate with cross-functional teams to ensure proper documentation and regulatory compliance throughout the project lifecycle.
6. Provide technical support for system commissioning, qualification, and troubleshooting.
7. Work with engineering teams to ensure system designs meet operational requirements and regulatory standards.
8. Ensure adherence to safety protocols, quality control processes, and regulatory compliance during commissioning and qualification activities.
9. Update and maintain project documentation, ensuring consistency and compliance with GMP and GDP practices.
10. Actively engage with project management teams and other stakeholders to ensure the project is progressing according to schedule.
Requirements:
1. BS Degree in Engineering, Science, or related technical discipline.
2. Minimum of 3 years in Commissioning and Qualification, ideally within the medical device, pharmaceutical, or related industries.
3. Hands-on experience with clean utilities, hygienic piping, process instrumentation, controls, and associated systems.
4. Familiarity with clean utility tie-ins to existing systems, such as upgrading purified water skids to support new tanks.
5. Strong understanding of sanitary equipment, hygienic piping, and process control systems.
6. Knowledge of risk-based commissioning and qualification approaches.
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