Validation Engineer
7 days ago
Job Title: Validation Engineer - Pharmaceutical
Location: Indianapolis, IN, 46241
Duration: 6+ Months Contract (possible extension of long term)
Experience:
- Pharmaceutical: 5 years (Required)
- Validation/Qualification: 5 years (Preferred)
Academic
- Bachelor's Degree in a Science, Engineering or relevant discipline
- 5+ years relevant pharmaceutical and/or validation/qualification experience
- Technical Qualifications:
- Must be familiar with Regulatory requirements and guidance applicable in area(s) of deployment
- Must be familiar with the relevant areas of science applicable in area(s) of deployment
- Must be familiar with the general areas of Technical knowledge / understanding
Job Description:
- 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.
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