Deskripsi Pekerjaan
Are you an experienced Validation Engineer looking for a challenging role in a cutting-edge scientific environment? Join a premier Science MNC in Singapore as an Equipment Validation Engineer, where you will spearhead validation activities across equipment, facilities, utilities, and processes. This is a unique opportunity to work in a highly regulated GMP setting, ensuring that systems meet the highest quality and compliance standards.
In this role, you will be responsible for the full validation lifecycle, from developing Validation Master Plans to executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). You will conduct risk assessments, manage change control, and author comprehensive validation documentation. Collaboration with engineering, production, and quality teams is essential to ensure seamless project execution.
Our client is a global leader in the life sciences industry, committed to innovation and excellence. They offer a supportive culture, continuous learning, and career development opportunities. If you have a strong technical background in validation and a passion for quality, this is the perfect next step in your career.
Key aspects of the role include leading FAT/SAT activities, troubleshooting validation issues, and supporting regulatory audits. You will also drive continuous improvement initiatives to enhance validation efficiency and effectiveness. This position requires a proactive individual who can manage multiple projects and communicate effectively across all levels of the organization.
Tanggung Jawab
- Develop and execute Validation Master Plans and IQ/OQ/PQ protocols for equipment and systems.
- Lead risk assessments and impact analyses to define validation scope and strategy.
- Author, review, and approve validation documentation, including protocols, reports, and deviations.
- Coordinate with cross-functional teams (Engineering, Quality, Production) to ensure smooth validation execution.
- Manage change control processes and ensure all modifications are validated per GMP requirements.
- Support regulatory inspections and audits by providing validation evidence and technical expertise.
- Drive continuous improvement in validation methodologies and best practices.
Kualifikasi
- Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical) or Life Sciences.
- Minimum 3 years of experience in equipment validation within a GMP-regulated environment (pharma, biotech, medical devices).
- Strong knowledge of GMP, FDA, and EU regulations.
- Hands-on experience with IQ/OQ/PQ, risk assessment, and change control processes.
- Excellent documentation, report writing, and communication skills.
- Proven ability to work cross-functionally and manage multiple projects simultaneously.
- Detail-oriented with strong analytical and problem-solving skills.
- Professional certification (e.g., CQE, CQA) is an added advantage.