Validation Expert
7 days ago
Futran Tech Solutions Pvt. Ltd. is seeking a talented Validation Expert to join their team in Seattle, WA.
Job SummaryThe Validation Expert will be responsible for defining and implementing process validation strategies and studies for lentiviral vector products. This role will develop process validation master plans, study designs, protocols, and reports, ensuring compliance with global health authority expectations and GMP concepts.
Responsibilities- Develop and implement validation policies to define robust process validation programs within the cell therapy product lifecycle.
- Participate in generation and approval of PPQ enabling deliverables generated during late-stage process development and characterization.
- Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment.
- Author CMC content for regulatory filings.
- Represent validation on contract manufacturing projects, including vendor selection, process transfer, and process validation.
- Bachelor's Degree in Life Sciences or Chemical Engineering.
- Minimum 5 years of experience in pharma/biotech industry, minimum 2 years of validation experience in a GMP environment.
- Excellent communication skills, both oral and written.
The estimated salary for this position is $110,000 - $140,000 per year, depending on experience.
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