Job Description
We are seeking a highly skilled CQV (Commissioning, Qualification, and Validation) Engineer to join our team for a significant pharmaceutical project in Singapore. This role involves ensuring that all systems and equipment are properly commissioned, qualified, and validated in compliance with GMP regulations.
Key Responsibilities
- Oversee the commissioning of pharmaceutical manufacturing equipment and systems to ensure they meet design specifications and regulatory requirements.
- Develop and execute qualification protocols (IQ, OQ, PQ) for equipment, utilities, and systems.
- Ensure that all processes are validated according to industry standards and GMP regulations.
- Prepare and maintain detailed documentation for all commissioning, qualification, and validation activities, including protocols, reports, and traceability matrices.
- Ensure all activities comply with GMP regulations, industry standards, and company policies.
- Work closely with project teams, including engineering, QA, and operations, to ensure seamless integration and project execution.
- Identify and resolve any issues that arise during the commissioning, qualification, and validation processes.
- Provide regular updates and reports to project stakeholders and management on the status of CQV activities.
Required Qualifications And Skills
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 5 years of GMP experience in commissioning, qualification, and validation within the pharmaceutical industry.
- Strong understanding of pharmaceutical manufacturing processes, equipment, and systems.
- Proficiency in developing and executing IQ, OQ, and PQ protocols.
- Excellent problem-solving and analytical abilities.
- Strong verbal and written communication skills, with the ability to interact effectively with team members and stakeholders.
- High level of accuracy and attention to detail in all aspects of work.
