Utilities Engineer (Pharma) (SG)
Date Posted: August 23, 2024
Job Description
We are seeking a highly skilled Utilities Engineer to join our pharmaceutical project team in Singapore. In this role, you will be responsible for the design, commissioning, qualification, and validation (CQV) of utility systems, ensuring that all processes meet stringent regulatory and quality standards. Your expertise will be essential in the successful delivery of this high-profile project, contributing to the overall operational efficiency and compliance of the pharmaceutical facility.
Key Responsibilities
- Lead the design, commissioning, qualification, and validation activities for utility systems, including HVAC, chilled water, steam, and compressed air systems.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for utility systems, ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
- Collaborate with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration of utility systems into the overall project.
- Review and approve design specifications, vendor documentation, and test plans related to utility systems.
- Perform risk assessments and gap analyses to identify and mitigate potential compliance issues.
- Ensure that all CQV documentation is accurate, complete, and meets internal and external audit requirements.
- Provide technical support during system troubleshooting and deviation investigations to ensure timely resolution.
- Participate in project meetings, providing updates on CQV activities and ensuring alignment with project timelines.
- Maintain up-to-date knowledge of industry best practices and regulatory changes related to utility systems in the pharmaceutical industry.
Required Qualifications and Skills
- Bachelor’s degree in Engineering, Mechanical Engineering, or a related field.
- Several years of experience in CQV activities, specifically with utility systems in the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP regulations, utility system design, and validation principles.
- Proficiency in developing and executing IQ, OQ, and PQ protocols.
- Excellent problem-solving and analytical skills.
- Ability to work collaboratively in a cross-functional team environment.
- Strong documentation and communication skills.
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
