Validation Technician

Job Title: Validation Technician

Shift: Friday - Monday 7 am - 5pm (only during training period) & Thursday Sunday 7 am 5 PM

Location: Indianapolis (Onsite role)

Pay Range: ***
- *** based on skills and qualifications

• 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.

• Bachelor’s Degree in a Science, Engineering or relevant discipline.
• 5+ years relevant pharmaceutical and/or validation/qualification experience.

• 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.

• Pharmaceutical: 5 years (Required).
• Validation/
  
  Qualification:
  
  5 years (Preferred).

• Bachelor's (Required).