Packaging Validation Associate I

Responsibilities

• Manage multiple projects providing technical support for packaging operations in a cross-functional environment
• Develop and execute validation documentation including Process Flow Diagrams, FMEAs, Protocols, and SOPs
• Assist Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
• Formulate and recommend validation procedures in accordance with business objectives
• Select packaging materials and evaluate components for functionality and machinability
• Act as Change Control Management (CCM) Owner and author Non-Conformance and OCR reports
• Identify and implement changes to Automated Inspection Machines

Requirements

• Bachelor’s degree in science or engineering preferred, or 5+ years manufacturing experience with 2 years of leadership
• Proficiency in Microsoft Word, Excel, and Outlook
• Ability to review Equipment Manuals, Engineering Drawings, and Electrical Schematic Diagrams
• Experience with enterprise software such as JDE, BPLM, or Trackwise preferred
• Understanding of cGMPs and regulatory guidelines for the pharmaceutical industry preferred

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) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.