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The Opportunity

The Senior Validation Engineer is primarily responsible for maintaining the site’s Right to Operate and enabling excellence in manufacturing by providing validation support to the production organization. This support ensures safe, high-quality, and continuously improving production.

The role involves owning, executing, and improving the validation lifecycle from planning to retirement for manufacturing processes and equipment. This includes, but is not limited to, oversight of Equipment, Facility, and Utility Qualification, Cleaning Validation, and Shipping Validation in partnership with Distribution. Additionally, the Senior Validation Engineer administers the Periodic Review and Revalidation Program. The Senior Validation Engineer is accountable for ensuring compliance with PQS and HA requirements and represents the Validation program during HA inspections. The role will reports to the Senior Validation Engineering Manager

As the Senior Validation Engineer, you are responsible for:

Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.

Develop, review and approval of Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards.

Provide guidance and direction on all validation activities at the Singapore site.

Ensure that all validation activities with respect to cleaning, sterilization and facilities/equipment stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.

Participate actively in investigations or troubleshooting discrepancies/ deviation encountered during commissioning and qualification.

Generate training materials, conduct workshops on validation activities, and serve as a technical subject matter expert (SME).

Provide on-call support for urgent validation requests, participate in site Validation Maintenance Program, and ensure compliance with Safety, Health & Environmental (SHE) requirements.

Project and Change Management: Lead validation activities for new product introductions, support change implementation, and participate in external regulatory inspections as an SME.

Continuous Improvement and Security: Promote validation awareness, embody Lean Production System (LPS) principles, and observe site security measures.

Who You Are:

Engineering/Science Degree or higher from recognised institution

Minimum 5 years of experience in Validation / Quality unit in the pharmaceutical/biotech industry or equivalent holders with combination of education and relative work experience

Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7) is preferred.

Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility

Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.

Must be highly motivated, able to work independently as well as a Team player, with strong focus on safety, quality and timeline.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.