Sr. Process Validation Engineer

Simtra BioPharma Solutions

8 days ago

3.1 on Glassdoor

Bloomington, Indiana, United States

Onsite

Full Time

Senior

0 applicants

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About this role

A Senior Process Validation Engineer at Simtra BioPharma Solutions leads validation activities for sterile injectable manufacturing processes in a regulated pharmaceutical CDMO environment. The role focuses on process validation strategy, execution, lifecycle management, and maintaining the validated state to ensure compliant, robust, and inspection-ready operations.

Skills

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline5–8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environmentStrong understanding of sterile injectable manufacturing processes and aseptic processing principlesSolid working knowledge of cGMP requirements and validation lifecycle conceptsDemonstrated experience authoring and executing process validation protocols and reports

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.