Senior Validation Scientist at Roche

The Position

• At Roche in Cape Town, we're seeking a highly motivated Senior Validation Scientist to join our innovative team. Reporting to the Qualification and Validation Lead, you’ll play a pivotal role in ensuring project deliverables related to qualification and validation are achieved. In this role, you’ll be responsible for ensuring that validation requirements are met for all existing and new equipment, facilities, utilities, and processes by preparing and executing detailed validation protocols aligned with relevant testing standards.
• As a Senior Validation Scientist, you will contribute to our commitment to excellence by spearheading validation projects, serving as a bridge between development and operational activities, and driving cross-functional collaboration to deliver world-class diagnostic and biopharmaceutical products.

Main Challenges

As a Senior Validation Scientist, you will:

• Serve as a key interface between development and operations to plan, execute, and complete a range of validation activities, from Qualification (IQ, OQ, PQ) to Process Validation, Cleaning Validation, and CSV.
• Design and execute sampling plans, technical protocols, and validation studies 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 collaborating with quality teams and supporting audits for validation compliance.
• Support investigations by initiating and managing corrective/preventive actions (CAPAs), non-conformance reports (NCRs), and change requests.
• Provide leadership by reviewing documentation, mentoring new and current team members, and applying statistical techniques to solve critical challenges in validation processes.
• 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 5 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:

• Extensive knowledge of process validation, pFMEAs, and statistical techniques for sampling plans and process capabilities.
• Exceptional skills in preparing and reviewing validation plans, protocols, and Standard Operating Procedures (SOPs).
• Practical experience in validation studies, including Process, Cleaning, Equipment Qualification (IQ, OQ, PQ), and CSV.

Core Competencies:

• Demonstrated ability to lead cross-functional teams with emotional intelligence and communicate effectively at all levels, both verbally and in writing.
• Excellent problem-solving and critical-thinking skills combined with attention to detail and the ability to independently manage changing priorities.
• Keen organizational capabilities and understanding of project management principles, 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, team-oriented, and flexible, with an eagerness to train and mentor colleagues while also learning from them.
• Previous experience in product development, coupled with the ability to work in ISO-regulated Quality Management Systems, will further strengthen your application.