Job Description
The CSV Engineer plays a pivotal role in ensuring ongoing validation compliance of computerized equipment and systems in sterile products manufacturing.
Key responsibilities include:
* Integrally involved in the validation of all new computerized equipment, and control systems
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized equipment and systems
* Participates in the change control process advising on CSV issues as appropriate
* Ensures projects are managed in compliance with all required legal requirements
* Designs implements and executes validation studies for manufacturing and control equipment
* Provides technical assistance on current US FDA and EU validation requirements for lyophilization aseptic processing and sterilization
* Ensures that the validation status of equipment and systems are in compliance with cGMP at all times
* Approves and implements changes to relevant systems and assists in generating validation revalidation plans
* Generates reviews and approves execution of the validation revalidation plans
Required Skills and Qualifications
* Degree in Science Chemistry Microbiology or Pharmacy preferred
* Post graduate studies as appropriate to augment primary degree
* 3 5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector
* 2 3 years experience in validation environment
* Project management experience
* Full understanding of relevant quality and compliance regulations
* Able to execute projects to plan
* Good knowledge of quality management systems
* Effective facilitator
* Good communication skills at organization team and individual levels
* Understands KPI's for the site
Benefits
This role offers an exciting opportunity to work in a dynamic environment and contribute to the success of the company.
Others
Please note that this is a general job description and may not include all duties or requirements associated with the position.