Senior Validation Scientist

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

At Roche in Cape Town were seeking a highly motivated Senior Validation Scientist to join our innovative team. Reporting to the Qualification and Validation Lead youll play a pivotal role in ensuring project deliverables related to qualification and validation are this role youll 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 heres 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.

This is your opportunity to make a profound impact at Roche contributing to innovative solutions that save lives worldwide. If youre a seasoned validation expert looking for your next challenge join us in Cape Town and shape the future of healthcare innovation.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience :

Senior IC

Key Skills

Laboratory Experience,Mammalian Cell Culture,Biochemistry,Assays,Protein Purification,Research Experience,Next Generation Sequencing,Research & Development,cGMP,Cell Culture,Molecular Biology,Flow Cytometry

Employment Type : Full-Time

Experience : years

Vacancy : 1