Validation Specialist

Description:

The holder of this position is charged with supporting the critical aspects of operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.

• Writing and executing media protocols, procedures and guiding documents for isolator fill line readiness.

• Provide guidance to manufacturing, working with the operator, focusing on manufacturing process and ensuring the quality and validation are in compliance with the requirements.

• Provide expertise on conducting assessments on documentation related to supply products manufacturing to adhere to Client QM, QD and global regulations.

• Interact/collaborate with Tech/Ops functions to facilitate transfer of knowledge and deliverables for the isolator fill line readiness.

• Monitor, and report on Key Performance Indicators (KPI) and performance measures of the validation team members to enable strategic objectives to be met for isolator fill line readiness.

• Understand, develop validation PQ approaches and perform PQ executions for the isolator fill line readiness.

• Contribute to validation policies, guidance documents (SOPs, VMPs, CPPs) detailing best practice approach with isolator fill line project focus.

Academic/Technical Qualifications:

• Bachelor’s Degree in a Science, Engineering or relevant discipline

• 5+ years relevant pharmaceutical and/or validation/qualification experience

Specialist/Technical Qualifications:

• Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment

• Must be (or quickly become) familiar with the relevant areas of science applicable in area(s) of deployment

• Must be (or quickly become) familiar with the general areas of technical knowledge / understanding

Experience:

• Pharmaceutical: 5 years (Required)

• Validation/Qualification: 5 years (Preferred)

Education:

• Bachelor's (Required)