Validation Quality Engineer
Quality Engineer (Validation)
Location: Singapore (Tuas)
About the Company
Our client is a multinational pharmaceutical company with a strong global presence, known for delivering high-quality healthcare products and maintaining rigorous standards across its manufacturing operations. The organization offers a collaborative and growth-oriented environment, with opportunities for professional development and exposure to international best practices.
The Role
This position is based at a manufacturing site in Tuas, Singapore. As a Quality Engineer (Validation), you will be responsible for ensuring that validation and change control activities are effectively executed in a timely and compliant manner, supporting overall product quality and regulatory requirements.
Key Responsibilities
- Ensure full compliance with company policies, quality standards, and regulatory requirements
- Develop, execute, and review validation protocols and associated documentation
- Lead Failure Mode and Effects Analysis (FMEA) for new equipment installations and process changes
- Manage site validation review processes and approve change controls related to plant and laboratory operations
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality events
- Support the resolution of validation-related issues and escalate risks appropriately
- Participate in equipment and process walkdowns
- Prepare and deliver weekly, monthly, and quarterly reports
- Support Quality Management Reviews (QMR) and Business Management Reviews (BMR)
- Coordinate validation and change control activities during planned plant shutdowns
- Drive continuous improvement projects within the business area
- Participate in internal and external audits
- Contribute to site-wide technical initiatives, knowledge sharing, and cross-functional projects
- Perform additional tasks as assigned by the supervisor
Requirements
Minimum Qualifications
- Degree in Science or Engineering
- Alternatively, a Diploma in Science or Engineering with at least 3 years of relevant experience
Preferred Qualifications
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) within pharmaceutical or food manufacturing environments
- Experience in developing SOPs and process workflows
- Familiarity with problem-solving methodologies (e.g., Fishbone, 5 Whys, 6M analysis)
- Understanding of international standards (e.g., ISO, FSSC) is an advantage
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
- Strong analytical and problem-solving skills with a focus on continuous improvement
- Experience with statistical tools such as Minitab or JMP is a plus
- Exposure to manufacturing or equipment design processes is beneficial
- Excellent communication skills and strong written English
- Self-motivated team player with a proactive approach
FAQs
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