Validation Specialist

Job DescriptionJob Description

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)

Company DescriptionLanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.Company DescriptionLanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.