Job description
Join Roche's Attach & Train program as a Validation Engineer Trainee, where you will own, execute, and continuously improve the validation lifecycle for manufacturing processes and equipmentāfrom planning to retirement. You will work in a GMP-regulated environment, collaborating with cross-functional teams to ensure processes deliver safe, effective, and compliant products for patients worldwide.
As a trainee, you will gain hands-on experience across validation planning, execution, documentation, and change control. You will support IQ/OQ/PQ activities, participate in risk assessments, and contribute to equipment qualification and process validation efforts. This role provides a structured path to develop technical expertise in validation science, quality systems, and regulatory readiness within Roche's manufacturing network in Singapore.
With mentorship from senior engineers and QA professionals, you will learn how to design robust validation strategies, analyze data, generate clear validation reports, and maintain thorough audit trails. You will also collaborate on deviation investigations, CAPA actions, and continuous improvement initiatives to enhance efficiency, product quality, and compliance.
Why Roche? You will be part of a global biopharma leader that values scientific rigor, innovation, and people development. The Attach & Train program is designed to accelerate your growth into a capable validation specialist who can support manufacturing operations across multiple sites, ensuring patient safety and regulatory compliance.
Expected projects include helping to qualify new equipment, evaluating process changes, and supporting internal and external audits. You will learn to document with precision, maintain validation master plans, and present findings to stakeholders. The role emphasizes ethical conduct, data integrity, and a proactive mindset.
Responsibility
- Develop, execute, and manage validation protocols for manufacturing processes and equipment across the lifecycle (IQ/OQ/PQ).
- Plan and perform risk assessments and ensure traceability of validation activities to quality systems and regulatory requirements.
- Collaborate with Manufacturing, Quality Assurance, Engineering, and Compliance teams to maintain GMP compliance and regulatory readiness.
- Prepare, review, and approve validation documentation, including master plans, protocols, reports, and change controls.
- Support commissioning, qualification activities, and equipment qualification, ensuring proper installation and configuration.
- Analyze validation data, compile clear reports, and present status to stakeholders and auditors.
- Identify continuous improvement opportunities to streamline validation processes and reduce cycle times.
- Assist in CAPA investigations and deviations, contributing to root cause analysis and corrective actions.
Qualification
- Bachelorās degree in Engineering, Science, or a related field; life sciences is a plus.
- Strong foundational knowledge of GMP, ICH guidelines relevant to validation (e.g., ICH Q7, ISO 13485 where applicable).
- Introductory experience with validation concepts (IQ/OQ/PQ), risk assessment, and change control.
- Analytical mindset with proficiency in data analysis tools (e.g., MS Excel, statistics basics) and documentation.
- Excellent written and verbal communication; disciplined documentation and record-keeping.
- Ability to work collaboratively in cross-functional teams in a fast-paced manufacturing environment and adapt to change.
- Willingness to participate in Rocheās Attach & Train program and pursue a career in validation within Singapore.