Sterility Assurance Validation Associate I

Responsibilities

• Document new processes and update existing protocols, SOPs, and summary reports
• Conduct development studies on critical equipment
• Onboard new client projects and manage syringe line validations
• Perform gap assessments and determine validation approaches
• Manage non-conformance investigations (NCR), CAPA, and change control management (CCM)
• Participate in client audits and respond to audit observations
• Lead syringe line media fills and manage summary closure
• Perform semi-annual HEPA filter certification testing

Requirements

• BS degree in a science-related field with laboratory experience OR High School diploma/GED with 6+ years of pharmaceutical/biotech experience
• Intermediate proficiency in Microsoft Office Suite
• Ability to use enterprise software such as JDE, BPLM, Pilgrim, Trackwise, or Ellab Valsuite Pro
• Strong technical writing and oral/written communication skills
• Ability to meet Grade A and B gowning requirements
• Ability to lift 50 lbs and work from ladders

Benefits

• Medical and Dental coverage
• 401(k) with company match
• Paid Time Off and Paid Parental Leave
• Education Assistance Program
• Employee Ownership Plan
• Onsite amenities including a workout facility and cafeteria

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.