Salary: High Salary: Cleaning Validation Specialist
Job Description:
Cleaning validation is a critical aspect of ensuring the quality and integrity of biopharmaceutical products. As a Cleaning Validation Technical Specialist, you will play a key role in supporting cleaning validation activities for the manufacture of biological bulk drug substance at our facility. Your responsibilities will include preparing and reviewing relevant documentation, providing input on cleaning processes, troubleshooting and supporting cleaning activities, and participating in regulatory agency inspections.
Required Skills and Qualifications:
To be successful in this role, you will need a degree qualification in a science or engineering discipline, with a minimum of three years' experience in cleaning validation, preferably in bulk drug substance manufacturing. You should also have experience in lean processing, preparation of routine documentation to GMP standard, and working with digital tools and applications. Additionally, you should have technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems, and regulatory requirements across multiple health authorities.
Benefits:
This role offers opportunities for professional growth and development, as well as the chance to work with a team of experienced professionals in a dynamic and fast-paced environment. You will have the opportunity to develop your skills and expertise in cleaning validation and contribute to the success of our company.
Others:
You will also be responsible for identifying operational process improvements using Lean Tools, assisting with the investigation of operations deviations through the eQMS system, and participating in technical projects, including process optimisation projects. Responsibility for Change Management and Deviation Management is also an essential part of this role.