CQV Utilities Engineer
Date Posted: March 7, 2024
Job Description
We are currently seeking a highly experienced CQV Utilities Engineer to join our pharmaceutical team in Singapore. The ideal candidate will have a minimum of 10 years of experience in the pharmaceutical industry, specializing in commissioning new equipment. Immediate availability is preferred.
Key Responsibilities
- Lead and oversee the commissioning, qualification, and validation (CQV) activities for utility systems in pharmaceutical manufacturing facilities.
- Develop and execute commissioning and qualification protocols for new utility equipment, ensuring compliance with regulatory requirements and industry standards.
- Collaborate closely with engineering, validation, and operations teams to integrate utility systems into existing manufacturing infrastructure.
- Provide technical expertise and troubleshooting support during commissioning and qualification activities, identifying and resolving issues as they arise.
- Ensure timely completion of CQV activities and documentation, including protocol execution, deviation management, and final report generation.
- Lead validation initiatives for critical utility systems, such as purified water, HVAC, and clean utilities, to ensure reliable and compliant operation.
- Develop and maintain comprehensive validation documentation, including standard operating procedures (SOPs), protocols, and reports.
- Stay abreast of industry trends and regulatory updates related to utility system validation and incorporate best practices into validation strategies.
Required Qualifications and Skills
- Bachelor’s degree in Engineering or related field.
- Minimum of 10 years of experience in commissioning, qualification, and validation of utility systems in the pharmaceutical industry.
- Extensive knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines, as they pertain to utility system validation.
- Proven track record of successfully commissioning and qualifying utility systems for pharmaceutical manufacturing facilities.
- Strong technical skills in HVAC, purified water systems, clean utilities, and other critical utility systems.
- Excellent project management abilities, with the capacity to lead cross-functional teams and manage multiple projects simultaneously.
- Effective communication and interpersonal skills, with the ability to collaborate with stakeholders at all levels of the organization.
- Detail-oriented mindset with a focus on quality and compliance.
- Proficiency in relevant software tools and documentation practices used in validation activities.
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
