Commissioning Engineer
The CQV Engineer plays a critical role in the production of drug substances, overseeing the commissioning, qualification, and validation of equipment, systems, and processes.
Key Responsibilities:
1. Develop Commissioning Plans: Create and execute commissioning plans for new and existing equipment and systems.
2. Ensure Proper Operation: Perform equipment start-up and troubleshooting to guarantee proper operation.
3. Qualification and Validation: Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems, analyzing data and preparing comprehensive reports.
4. Process Validation: Develop and execute validation protocols for processes and computer systems, conducting risk assessments and gap analyses to identify critical process parameters and control strategies.
5. Documentation Management: Prepare and maintain detailed documentation, including protocols, reports, and standard operating procedures (SOPs).
6. Project Management: Manage multiple CQV projects simultaneously, ensuring timely completion and adherence to project timelines.
Requirements:
* Education: Bachelors degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
* Experience: Experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
* Regulatory Knowledge: Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements.
* Technical Skills: Proficiency in developing and executing IQ/OQ/PQ protocols, familiarity with risk-based approaches to validation (e.g., ASTM E2500), experience with process validation and computer system validation.
Skills:
* CQV Commissioning
* Project Management
* IQ OQ PQ