Job Title: Validation Technician
Location:Indianapolis, IN 46241
Duration: 03 months
Schedule: Monday 7 am - 5pm (only during training period) & Thursday – Sunday 7 am – 5 PM
Position Requirements:
· 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 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
· Lifting is required (30 lbs)
Experience:
· Pharmaceutical: 5 years (Required)
· Validation/Qualification: 5 years (Preferred)
Education:
· Bachelor's (Required)