Equipment CQV Engineer
Date Posted: May 24, 2024
Job Description
We are currently seeking a skilled CQV (Commissioning, Qualification, and Validation) Engineer with extensive experience in equipment validation within the pharmaceutical industry to join our team for an exciting project based in Singapore. The ideal candidate will have a minimum of 7 years of experience in equipment validation and will be responsible for ensuring that all equipment and systems meet the required standards for performance and regulatory compliance.
Key Responsibilities
- Develop and execute commissioning, qualification, and validation (CQV) protocols for pharmaceutical equipment and systems.
- Ensure that all equipment and systems are validated according to industry standards and regulatory requirements, including GMP and FDA regulations.
- Collaborate with cross-functional teams to define validation requirements and develop validation plans.
- Conduct risk assessments and gap analyses to identify potential issues and develop mitigation strategies.
- Oversee the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Prepare and maintain comprehensive validation documentation, including protocols, reports, and standard operating procedures (SOPs).
- Provide technical support and troubleshooting expertise for validation-related issues, ensuring timely resolution.
- Stay informed about industry trends, regulatory changes, and best practices in equipment validation, and propose innovative solutions to enhance validation processes.
- Ensure compliance with all applicable regulations, standards, and company policies throughout the validation process.
Required Qualifications and Skills
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 7 years of experience in equipment validation within the pharmaceutical industry.
- Strong understanding of pharmaceutical manufacturing processes and regulatory requirements (e.g., GMP, FDA).
- Proven experience in developing and executing CQV protocols, including IQ, OQ, and PQ.
- Excellent problem-solving skills and the ability to work effectively in a fast-paced, team-oriented environment.
- Strong communication skills, with the ability to effectively interact with stakeholders at all levels of the organization.
- Proficiency in validation-related software and tools.
- Proven track record of successful project delivery and adherence to project timelines and budgets.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
