Aseptic Filling Specialist

Overview:

The Aseptic Filling Specialist is a key technical contributor responsible for supporting sterile manufacturing operations and ensuring high-quality aseptic production performance. This hands-on role involves operating and maintaining advanced filling equipment, executing production cycles, and driving continuous improvement initiatives to optimize efficiency, safety, and compliance. The position requires strong mechanical aptitude, problem-solving ability, and leadership in guiding operators on proper aseptic technique and equipment best practices. 

Job Responsibilities:

• Perform aseptic manipulations within Grade A isolators and execute production activities in Grade C, D, and controlled environments.

• Set up, operate, and perform changeovers on sterile filling and supporting equipment in compliance with cGMP procedures.

• Lead batch startup, in-process monitoring, and completion of production documentation with precision and accuracy.

• Troubleshoot and resolve equipment and process issues to maintain consistent manufacturing output.

• Serve as a Subject Matter Expert (SME) for aseptic filling systems, providing technical guidance and hands-on support.

• Support and execute validation and engineering protocols related to filling and component preparation processes.

• Participate in FMEAs and other risk-based assessments to strengthen process robustness and ensure product quality.

• Train and mentor operators on aseptic technique, equipment operation, and production best practices.

• Drive continuous improvement projects focused on equipment optimization, process reliability, and operational efficiency.

• Apply Good Engineering Practices (GEP) and Lean principles to enhance manufacturing performance and compliance.

• Collaborate with cross-functional teams to implement corrective actions and process improvements.

• Maintain adherence to all safety, environmental, and quality standards within the cleanroom environment.

Job Qualifications:

• High school diploma or equivalent with 3+ years of GMP pharmaceutical manufacturing experience, specifically in aseptic processing (fill/finish).

• Demonstrated proficiency in setup, operation, cleaning, and maintenance of GMP manufacturing equipment.

• Strong mechanical aptitude and hands-on troubleshooting skills for automated and manual filling systems.

• Working knowledge of cGMPs, Good Documentation Practices (GDP), and aseptic technique requirements.

• Proficiency with MS Office and ability to learn manufacturing and inventory management systems (ERP, MES, etc.).

• Excellent communication skills with the ability to lead, train, and collaborate across production teams.

• Strong attention to detail, data accuracy, and adherence to compliance standards.

• Ability to perform mathematical calculations relevant to production operations (fractions, ratios, percentages).