Job Description
Responsibilities
- Support a variety of Validation projects across the Pharma and /or Biologics sites
- Interact with other departments to ensure that validation projects are appropriately planned, executed and delivered in a timely manner
- Generation of SDLC documentation in line with current regulatory and corporate requirements
- Maintaining an up to date knowledge of relevant regulatory requirements
- Support any Departmental initiatives in relation to safety, quality and cost
Qualifications And Experience
- Minimum 3rd level Science / Engineering Qualification.
- Minimum 2 years' experience working in a Validations environment
- Comprehensive understanding of Validation principles and practices
- Good working knowledge of Validations practices, ASTM and relevant EU/FDA regulations.
- A proven track record that demonstrates the ability to work without direct supervision whilst maintaining adherence to project delivery is fundamental to the role
- Some travel may be required intermittently to support the execution of Factory Acceptance Tests
Skills
- Equipment Qualification
- Process Performance Qualification
- Autoclave / SIP Validation
- CSV
