Validation Engineer Trainee – Attach & Train Program

About the role

Roche is hiring a Validation Engineer Trainee for its Singapore site under the Attach & Train program. The role supports the production organization in maintaining the site's Right to Operate and delivering safe, high-quality, continuously improving manufacturing. It covers the full validation lifecycle from Plan to Retire, including Equipment, Facility and Utility Qualification, Cleaning Validation, Shipping Validation and the Periodic Review and Revalidation Program, in partnership with Distribution.

Key responsibilities

• Support the day-to-day operation of approved Validation SOPs, plans and policies at a multi-platform, multi-product GMP biotech contract manufacturing facility.
• Develop Validation SOPs, templates, guidelines, protocols and reports, including site discrepancy and deviation investigations and closures.
• Guide validation activities at the Singapore site and ensure they follow policies, standards and procedures and are completed on time.
• Take part in investigations of discrepancies and deviations during commissioning and qualification.
• Generate training materials and run workshops on validation activities, and act as a technical subject matter expert.
• Prepare and review Turnover and Vendor packages, support change implementation and site validation maintenance.
• Support validation and QA audits, including material traceability audits, and take part in external regulatory inspections as SME.
• Help raise awareness of the importance of validation at the site and in the industry, and comply with safety, health and environmental requirements.

Required profile

• Degree in Life Sciences or Engineering, or equivalent.
• 0-3 years of related experience for degree holders, or equivalent mix of education and experience.
• Experience in a biotech or pharmaceutical environment is preferred.
• Meticulous, systematic, adaptable to changing priorities, and able to work independently and as a team player with a strong focus on safety, quality and timelines.

Required skills

• Familiarity with regulatory requirements and local codes and standards such as FDA, EMEA, GAMP and ICH Q7.
• Good knowledge of validation programs in GMP facilities.
• Good oral and written communication skills.