job description
Are you an experienced Commissioning and Qualification (C&Q) Engineer looking to advance your career with a leading global Pharmaceutical MNC? We are seeking a highly skilled professional to join a dynamic project team in the West Region of Singapore. In this role, you will be instrumental in ensuring that our cutting-edge manufacturing facilities meet the highest standards of safety, compliance, and operational excellence.
You will lead critical C&Q activities, managing the lifecycle of equipment and systems from design verification to final handover. This position offers an excellent opportunity to work on large-scale pharmaceutical projects, collaborating with cross-functional teams to drive process innovation and maintain regulatory readiness in a fast-paced environment.
Responsibility
- Plan and execute commissioning and qualification activities for pharmaceutical manufacturing equipment and utilities.
- Develop and review C&Q documentation, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Lead risk assessment workshops and ensure compliance with GAMP 5 and cGMP guidelines.
- Coordinate with vendors, engineering teams, and quality assurance departments to resolve technical issues during project execution.
- Oversee system testing, start-up, and troubleshooting to ensure equipment meets validated state requirements.
- Prepare final summary reports and manage the handover process to operations and maintenance teams.
Qualifications
- Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or a related field.
- Minimum 3-5 years of experience in C&Q within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of FDA, EMA, and HSA regulatory requirements.
- Proven expertise in cleanroom environments, HVAC systems, and process equipment validation.
- Strong problem-solving skills with a high level of technical accuracy and attention to detail.
- Excellent communication and project management skills to work effectively in an MNC setting.
- Ability to interpret P&IDs, electrical schematics, and functional specifications.