Principal Validator

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.