Manager, Aseptic Process Operations

The Impact You Will Make

The Aseptic Operations Support Manager is a critical role within our Aseptic Pharmaceutical Manufacturing Facility. This position is designed to engage and provide in-depth knowledge and expertise to cross-functional operational functions and ERP system across all production areas, to include but no limited to formulation, clean and prep, sanitization, aseptic filling, material handling, and warehouse operations.

Role Responsibilities

• Provide operational coverage and expertise across all manufacturing areas: formulation, clean and prep, filling, sanitization, material handling, and warehouse.
• Serve as a SME and mentor for manufacturing processes and ERP-related tasks.
• Act as the site expert in ERP system usage, specifically Microsoft Dynamics 365, supporting all users with training, real-time troubleshooting, and transactional oversight to achieve positive outcomes.
• Manage all real-time ERP shop floor transactions, with a focus on identifying and resolving variances, ensuring accurate material consumption, batch reconciliation, and inventory movements.
• Float across areas to support operational gaps, provide temporary leadership coverage, or conduct targeted training and oversight sessions.
• Provide support to off-shifts, as needed, particularly regarding ERP transaction resolution and training.
• Ensure compliance with cGMP, data integrity, and aseptic processing principles during all job functions and while training others.
• Support continuous improvement initiatives and identify opportunities to streamline ERP transactions and manufacturing processes.
• Partner with Quality, Operations, and Training departments to ensure proper documentation, training records, and procedural compliance.
• Provide operational excellence, right-first-time execution, and strong communication.

Basic Qualifications

• Bachelor's degree in science, engineering, or business administration required.
• Minimum of 10 years of experience in aseptic pharmaceutical manufacturing or equivalent combination of education and practical expertise.
• Demonstrated experience with ERP systems required; expertise in Microsoft Dynamics 365 strongly preferred.
• Financial and operational fluency in manufacturing environments with a focus on variance management and production accuracy.
• Subject matter expertise in aseptic manufacturing processes including formulation, clean and prep, sanitization, and filling.
• Proven ability to train others in both technical execution and ERP transaction compliance.
• Excellent verbal and written communication skills; ability to write and deliver technical training content.
• Strong analytical and problem-solving skills, particularly in real-time manufacturing environments.
• High degree of organizational skills, attention to detail, and commitment to quality.
• Able to work cross-functionally with production, quality, IT, and warehouse teams.