Sterility Assurance Validation Associate I (1st Shift)

Simtra BioPharma Solutions(14 days ago)

Indiana, United States, Bloomington, INOnsiteFull TimeJunior$60,000 - $80,000Validation/Quality Assurance

About this role

The Sterility Assurance Validation Associate I is responsible for managing and executing project and system validations related to equipment and processes in a pharmaceutical manufacturing environment. The role ensures compliance with industry and regulatory standards, working closely with clients and internal teams at a core facility. This position emphasizes quality, safety, and collaboration to support the manufacturing of life-changing medicines.

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Required Skills

Validation
SOPs
Regulatory Compliance
Technical Writing
Equipment Qualification
Project Management
GMP
Audit
Process Validation
Automation

About Simtra BioPharma Solutions

simtra.com

Simtra BioPharma Solutions is a contract development and manufacturing organization (CDMO) focused on sterile injectable products. They offer end-to-end services — from formulation and analytical development through aseptic fill/finish, packaging, quality and regulatory support — to advance programs from clinical stages to commercial supply. Simtra emphasizes flexible product delivery options and a compliance-driven approach to meet biopharma partners’ timelines and manufacturing requirements.

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