Sterility Assurance Validation Media Team Associate I

Simtra BioPharma Solutions is seeking a Validation Media Team Associate I to lead media fills, manage intervention risk, and communicate with clients and auditors. This role reports to the Supervisor, Sterility Assurance Validation, and focuses on ensuring the quality of injectable products through a cGMP manufacturing environment. The position involves creating documentation, executing testing studies, and participating in client audits.

Requirements

• Interacting with clients evaluating projects against existing media fill processes.
• Creating and executing visual smoke testing studies.
• Performing investigations, process improvements, and changes.
• Participating in client audits and providing rationale with support.
• Serving as a subject matter expert for validation processes.
• Leading media fill challenges and providing oversight.

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan
• Time Off Program
• Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Onsite Campus Amenities
• Adoption Reimbursement Program
• Education Assistance Program