About the role
AI summarisedJoin Roche and contribute to maintaining the site’s Right to Operate by providing crucial validation support to a GMP biotech contract manufacturing facility. This role involves owning and executing improvements across the validation lifecycle, ensuring compliance with global quality standards while driving manufacturing excellence.
BiopharmaOnsite
Key Responsibilities
- Support the day-to-day operation of approved Validation SOPs/Plans/Policies within a multi-platform, multi-product GMP biotech contract manufacturing facility.
- Develop Validation SOPs, templates, guidelines, Validation Protocols, and Reports, including investigating and closing site discrepancies and deviations.
- Provide technical guidance on all validation activities concerning process, cleaning, facilities/equipment, and computerized systems.
- Ensure all validation activities adhere to relevant policies, standards, procedures, and guidelines in a timely manner.
- Generate training materials and conduct workshops on general validation activities.
- Serve as a technical Subject Matter Expert (SME) supporting department functions and participating in the site Validation Maintenance Program.
- Prepare and review Turnover/Vendor Packages and support Change Implementation on site.
Requirements
- Degree in Life Sciences or Engineering discipline or equivalent.
- 0-3 years of related working experience for degree holders or equivalent with relevant combination of education and work experience.
- Good knowledge of the practical and theoretical requirements of a validation program in a GMP facility.
- Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP, ICHQ7).
- Strong oral and written communication skills.
- Meticulous, systematic, and highly motivated with a strong focus on Safety, Quality, and timeline.
- Ability to adapt to rapidly changing priorities and support operations according to the manufacturing schedule.