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
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)
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
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)
