Validation Scientist at Roche

The Position

• At Roche in Cape Town, we're seeking a highly motivated Validation Scientist to join our innovative team. Reporting to the Qualification and Validation Lead, you’ll play a pivotal role in ensuring that validation requirements are met for all new and existing equipment, facilities, utilities, and processes. In this role, you’ll be responsible for preparing and executing detailed validation protocols that align with relevant testing standards and requirements.
• As a Validation Scientist, you will contribute to our commitment to excellence by supporting the execution of validation activities, driving cross-functional collaboration, and ensuring all deliverables are met on time.

Main Challenges
As a Validation Scientist, you will:

• Plan, develop and execute validation protocols for Qualification (IQ, OQ, PQ), Process Validation, Cleaning Validation, and CSV.
• Design and execute validation sampling and testing plans and protocols while troubleshooting and resolving technical issues encountered during execution.
• Manage and organize multiple competing priorities arising from unscheduled events or project timelines.
• Maintain adherence to evolving regulatory standards and guidelines by supporting internal and third-party audits for validation compliance.
• Provide support by reviewing validation plans, protocols, and Standard Operating Procedures (SOPs) written by other team members.
• The role demands a solution-oriented mindset, strong attention to detail, independence, and resilience in a dynamic team environment.

Who You Are as Our Ideal Candidate

• You are a scientific or engineering professional with a degree in a relevant discipline and at least 3 years of experience in validation or product development within the diagnostic, pharmaceutical, or biotech industry. Beyond your strong technical expertise, here's what makes you stand out:
• Validation Expertise: Strong skills in preparing and reviewing validation plans, protocols, and SOPs. Practical experience in validation studies, including Process, Cleaning, Equipment Qualification (IQ, OQ, PQ), CSV, and TMV.
• Core Competencies: Demonstrated ability to work effectively with cross-functional and cross-cultural teams in multiple locations and communicate effectively at all levels, both verbally and in writing. Excellent problem-solving and critical-thinking skills combined with a strong attention to detail. Strong organizational capabilities and ensuring timelines and deliverables are met.
• Key Attributes: Open-minded and adaptable, with a strong work ethic and the ability to thrive in a constantly evolving environment. Accountable, self-motivated, and flexible, with an eagerness to take initiative and work independently with minimal supervision. A working knowledge of ISO Quality Management systems is preferred.