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The Aseptic Manufacturing & Filling Specialist is responsible for the preparation, compounding, filtration, aseptic filling, visual inspection, and packaging of sterile drug products manufactured within a 503B outsourcing facility. This role ensures all manufacturing activities are performed in compliance with Current Good Manufacturing Practices (cGMP), aseptic processing requirements, contamination control systems and techniques, and established Standard Operating Procedures (SOPs). The Specialist works closely with Quality Assurance, Quality Control, Engineering, and Environmental Monitoring teams to ensure safe, compliant, and efficient production of sterile injectable medications.
Key Responsibilities
Aseptic Manufacturing Operations
- Perform aseptic compounding, formulation preparation, sterile filtration, filling and visual inspection activities according to approved batch records and SOPs.
* Prepare and verify raw materials, components, and equipment prior to manufacturing activities.
* Execute manufacturing operations within ISO classified cleanroom environments while practicing strict aseptic techniques.
* Perform line setup, equipment assembly, and pre-use inspections before batch processing, and batch reconciliation actions.
* Monitor critical process parameters and document all manufacturing activities accurately and contemporaneously.
Aseptic Filling, Inspection and Packaging
- Operate and monitor aseptic filling equipment, pumps, filtration systems, and related production equipment.
* Perform vial, syringe, or IV bag filling operations in compliance with validated manufacturing processes.
* Ensure proper container closure integrity and visual inspection requirements are met during production.
* Conduct line clearance and product changeover activities following approved procedures.
* Perform labeling, packaging, and final product handling activities as required.
Cleanroom & Contamination Control Compliance
- Adhere to cleanroom gowning procedures, personnel qualification requirements, and aseptic behavior standards.
* Maintain strict compliance with contamination control strategies and sterility assurance practices.
* Support environmental monitoring activities including viable and non-viable monitoring during production.
* Identify and report potential contamination risks, cleanroom excursions, or process abnormalities.
* Ensure manufacturing areas remain inspection-ready and compliant with facility standards.
Equipment Cleaning, Operation & Maintenance
- Perform equipment setup, cleaning, sanitization, and basic troubleshooting activities.
* Complete equipment logs, usage records, and cleaning documentation accurately.
* Verify equipment calibration status prior to use.
* Support preventive maintenance and validation activities when assigned.
* Escalate equipment malfunctions or deviations to supervision and Quality Assurance.
Documentation & Batch Record Compliance
- Complete Batch Production Records (BPRs) accurately and in accordance with ALCOA+ data integrity principles.
* Document all manufacturing steps, process checks, equipment usage, and material reconciliation activities.
* Review production documentation for completeness and accuracy before submission to Quality Assurance.
* Ensure deviations, discrepancies, and non-conformances are documented promptly and completely.
* Maintain compliance with document control requirements and Good Documentation Practices (GDP).
Deviation, Investigation & Continuous Improvement Support
- Report manufacturing deviations, atypical events, and procedural discrepancies immediately.
* Participate in investigations related to manufacturing events, environmental excursions, or process failures.
* Assist in implementation of corrective and preventive actions (CAPAs).
* Support process improvements, efficiency initiatives, and manufacturing optimization projects.
* Contribute to a culture of quality, compliance, and continuous improvement.
Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related field preferred.
* 1-3 years of experience in aseptic pharmaceutical manufacturing, sterile compounding, or sterile injectable production within a 503B, 503A, or pharmaceutical manufacturing environment.
* Worked in ISO classified cleanrooms and aseptic processing environments.
* Knowledge of CGMP regulations, FDA 503B requirements, USP <797>, USP <800>, USP <825>, and Annex 1 guidance.
* Experience with aseptic filling operations, sterile filtration, and manufacturing documentation.
* Strong understanding of contamination control principles and sterile manufacturing processes.
Competencies
- Strong aseptic technique and cleanroom discipline.
* High attention to detail and commitment to quality.
* Ability to follow complex manufacturing procedures and batch records accurately.
* Strong problem-solving and troubleshooting skills.
* Effective communication and teamwork across multiple departments.
* Ability to work in a fast-paced, highly regulated manufacturing environment.
* Commitment to patient safety, sterility assurance, and compliance excellence.
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