CQV Engineer

A CQV Engineer will work on the initial commissioning and qualification of equipment and equipment systems to ensure they are installed correctly and are fit for purpose, playing a vital role in ensuring that systems, facilities, and equipment meet design requirements and regulatory standards.

J ob Duties & Responsibilities (non exhaustive list) :

1. Commissioning : Oversee the start-up of manufacturing systems, ensuring they are installed correctly and function as intended.

2. Qualification : Develop and execute qualification protocols (Installation Qualification, Operational Qualification, Performance Qualification) to prove that systems and equipment are fit for their intended use.

3. Validation : Create an evidence trail to demonstrate consistent and reproducible results, ensuring processes meet predetermined specifications.

4. Documentation : Prepare and maintain detailed documentation for all CQV activities, including protocols, reports, and traceability matrices.

5. Compliance : Ensure all activities comply with Good Manufacturing Practices (GMP) regulations, industry standards, and client company policies.

6. Collaboration : Work closely with project teams, including engineering, quality assurance, and operations, to ensure seamless integration and project execution from start to finish successfully.

7. Problem-Solving : Identify and resolve issues that arise during commissioning, qualification, and validation processes.

8. Reporting : Provide regular updates and reports to project stakeholders and management on the status of CQV activities.

Essential Skills and Experience :

1. Bachelor's degree in Engineering or related field.

2. Minimum 5 years of GMP experience in commissioning, qualification and validation within the pharmaceutical industry with strong track record.

3. Proficiency in developing and executing IQ, OQ, and PQ protocols and other technical skills and competencies associated to CQV engineering.

4. Excellent problem-solving and analytical skills.

5. Ability to work effectively in a team environment.

6. Excellent communication and interpersonal skills.

7. Detail-oriented with a focus on quality and compliance.

8. High level of accuracy and attention to detail in all aspects of work. Ability to work on site in Tuas facility.

Job Type : Full Time - Work Mode : On-site - Country : Singapore - Region : Tuas, Singapore (West)