COMPUTER SYSTEM VALIDATION ENGINEER

The Company
A leading innovator in cancer immunotherapy and engineered T cell therapy, this organization is at the cutting edge of developing personalized treatments that are transforming the landscape of cancer care. With a dynamic, fast-moving environment, it fosters discovery and continuous improvement, offering talented individuals the chance to contribute to groundbreaking therapies that aim to save lives and improve patient outcomes.

Role Description
We are seeking a dedicated Senior Quality Engineer specialized in Computer System Validation to support MES (Manufacturing Execution System) projects. This role involves overseeing qualification and validation activities to ensure their systems meet all regulatory requirements and quality standards.

Responsibilities
- Support the development of KPIs to drive continuous improvement across the organization
- Develop strategies for implementing process changes
- Review and approve all CSV (Computer System Validation) deliverables, including initial validation, change-based validation, and revalidation activities
- Build knowledge of products and contracts to ensure quality compliance
- Collaborate across functions to improve organizational processes and interact effectively with team members
- Prioritize work to meet departmental goals with minimal supervision
- Ensure compliance with applicable regulatory requirements and GMP standards
- Assist with compliance audits as needed
- Support CQV quality oversight activities and risk management initiatives

Requirements
- Proven experience in computer system validation and quality assurance within a regulated environment
- Strong knowledge of GMP guidelines and regulatory standards
- Ability to develop strategies and support process improvements
- Experience in performing validation reviews and approvals
- Good collaboration and communication skills
- Ability to work independently and prioritize effectively

Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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