Aseptic Process Simulation Program Coordinator

📋 Description

• Lead the site-wide Aseptic Process Simulation (APS/Media Fill) program to ensure compliance with
• Develop, maintain, and execute the annual media fill strategy, including routine, validation, and
• Serve as the subject matter expert (SME) for aseptic process simulation design, execution
• Collaborate with Manufacturing, Quality Assurance, Microbiology, Engineering, and Validation teams
• Author, review, and approve APS protocols, risk assessments, reports, and associated quality system
• Lead investigations, root cause analyses, and corrective and preventive actions (CAPA) related to

🎯 Requirements

• Bachelor’s degree in science or technical field. MBA degree is beneficial and preferred.
• 5-10 years of experience in areas such as supply chain, customer service, manufacturing
• Strong Strategy development and planning skills coupled with necessary knowledge of pharmaceutical
• Strong issue identification and problem analysis, with the ability to create and execute solutions
• Proficiency with common program management communication software tools and techniques.
• Knowledge of business financial systems and tools.

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Eligible to participate in short-term incentive programs