Job Opportunity:
This is a 12-month contract opportunity for a Junior CSV Engineer to join our company that fosters a collaborative and inclusive environment.
Key Responsibilities:
* Integrally involved in the validation of all new computerized equipment and control systems
* Generates validation documentation and provides assistance with protocol execution
* Participates in change control process advising on CSV issues
* 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
* Maintains validation documentation and ensures compliance with cGMP at all times
Key Skills & Qualifications:
* Degree in Science (Chemistry, Micro., or Pharmacy) or Engineering (Chemical/Mech/Elec)
* Post-graduate studies as appropriate to augment primary Degree
* 3-5 years experience working in a Healthcare manufacturing environment
* 2-3 years experience in validation environment
* Project management experience
About this role:
This role is ideal for someone with a background in writing validation protocols and reports, and looking to gain more practical knowledge in Computer Systems Validation. The successful candidate will support site-wide operations and work closely with the team to ensure compliance with regulatory requirements.