Job Title: Junior CSV Engineer
We are seeking a talented and experienced Junior CSV Engineer to join our team. The successful candidate will be responsible for the validation of all new computerized equipment, control systems, and manufacturing processes at our site.
The ideal candidate will have a strong understanding of Computer Systems Validation principles and practices, as well as experience in writing validation protocols, reports, and compliance documentation.
Key Responsibilities:
* Validate new computerized equipment, control systems, and manufacturing processes.
* Generate validation documentation (protocols/reports) and provide assistance with the execution of protocols.
* Participate in the change control process advising on CSV issues.
* Develop and execute DQ, IQ, OQ, and PQ activities.
* Ensure projects are managed in compliance with all required Sanofi and legal requirements.
Required Skills and Qualifications:
* Bachelor's degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
* 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.
* Capable of troubleshooting validation issues associated with projects, process development etc.
* Competent technical knowledge of pharmaceutical plants.
* Knowledge of requirements for GAMP, ISPE Baseline guides.
* Full understanding of relevant quality and compliance regulations.
* Able to execute projects to plan.
* Good knowledge of quality management systems.
* Good communication skills at organization, team and individual levels.
* Understands KPI's for the site.
Benefits:
* 12-month contract opportunity.