Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Opportunity

As the Validation Engineer/(Senior) for Roche Singapore Technical Operations, you play a key role in ensuring the operational rights and promoting manufacturing excellence through validation support. It involves managing the validation lifecycle for manufacturing processes and equipment, including various qualifications and validations. The role also includes compliance with Roche quality standards and Health Authority requirements, and representation during inspections.

The Validation Engineer/(Senior) is responsible for

Support and manage validation SOPs, plans, and policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.

Develop, review, and approve Validation SOPs, templates, guidelines, Validation Protocols and Reports, and support site discrepancies and deviations investigation/closure.

Guide all validation activities at the Singapore site.

Ensure compliance with relevant policies, standards, procedures, and guidelines for all validation activities related to cleaning, sterilization, and facilities/equipment.

Lead investigations or troubleshooting discrepancies/deviations encountered during commissioning and qualification.

Generate training materials and conduct workshops on general validation activities & serve as a technical SME in support of department functions and provide on-call support for urgent requests.

Participate in site Validation Maintenance Program and new product introduction projects. Promote safety and security by complying with all RSTO’s SHE requirements, observing site security measures, and embodying Lean principles for continuous improvement.

Who you are

You hold an Engineering/Science Degree or equivalent from recognized institution with 3 years and above of experience in Validation / Quality unit in the pharmaceutical/biotech industry or equivalent holders with a combination of education and relative work experience

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

Proficient understanding and hands-on experience with both practical and theoretical aspects of validation programs in a GMP (Good Manufacturing Practice) facility.

Adaptable and flexible in managing rapidly changing priorities, with a commitment to supporting operations in alignment with the manufacturing schedule.

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.