We are seeking a CSV Engineer to join our organization.
As a CSV Engineer, you will be responsible for supporting the validation and compliance of computerized equipment and systems in a sterile pharmaceutical manufacturing environment. This role involves hands-on validation activities, ensuring adherence to regulatory and quality standards, and collaborating with cross-functional teams to maintain compliance.
Required Skills and Qualifications:
* Bachelor's degree in Science or Engineering, such as Chemistry, Microbiology, Pharmacy, Chemical, Mechanical, or Electrical engineering.
* Strong understanding of GAMP and ISPE Baseline Guides, as well as quality management systems.
* Hands-on experience in validation activities within a healthcare or pharmaceutical manufacturing environment.
* Knowledge of cGMP regulations and compliance requirements.
* Effective communication and facilitation skills across teams and organizational levels.
* Ability to manage projects effectively and meet key performance indicators (KPIs).
* Problem-solving mindset with adaptability and resilience.