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Validation Scientist

Validation Scientist

RocheCape Town, Western Cape, South Africa
30+ days ago
Job description

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.

Position

At Roche in Cape Town were seeking a highly motivated Validation Scientist to join our innovative team. Reporting to the Qualification and Validation Lead youll play a pivotal role in ensuring that validation requirements are met for all new and existing equipment facilities utilities and this role youll 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

  • 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 heres 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.

    • Who we are

    A healthier future drives us to innovate. Together more than 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.

    Key Skills

    Laboratory Experience,Immunoassays,Machine Learning,Biochemistry,Assays,Research Experience,Spectroscopy,Research & Development,cGMP,Cell Culture,Molecular Biology,Data Analysis Skills

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    Scientist • Cape Town, Western Cape, South Africa