Validation Engineer

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Abacus Service Corporation, is seeking the following. Apply via Dice today!

Note: C2C is not allowed

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)