2Nd Shift Aseptic Filling Technician

Job Summary

The Aseptic Filling Technician, Level I will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the Aseptic Filling Technician, Level I will work hands on, under ISO7 and ISO5 areas with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set-up, documentation of tasks in cGMP logbooks and Batch Records, submitting samples, and performing filling operations aseptically in ISO5 areas.

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Knowledge of current Manufacturing Practices (GXP) guidelines.
• Reports any accidents, incidents, and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace.
• Prepares for production run by reviewing the production schedule; identifying batch specific requirements; setting up the filling lines as per batch record instructions and applicable SOPs.
• Takes ownership of individual training plan.
• Responsible for reviewing all documentation including executed batch records and logbooks in "Real Time and Right First Time" and demonstrating error free documentation. Immediately reports errors or discrepancies to management.
• Obtaining equipment and required components for filling operations.
• Follows all steps outlined in batch records, ability to actively perform all tasks being required by the batch record/ SOPs.
• Ability to perform a batch record review in real time.
• Ability to operate aseptically in ISO 5 Cleanrooms.
• Customer/ Client Focus
• Ethical Conduct, respect for others, and solidarity.
• Technical Capacity to operate and troubleshoot processing equipment.
• Conscientiousness for work and documentation.
• Other duties and responsibilities as assigned.

Qualifications & Requirements

• High School diploma with 2 years -Pharma/Biotech Manufacturing Support and 1 year- within Clean Room environments and some technical certification is desired in related field.
• Two years of experience working in ISO 5 areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
• Strong organizational skills with the proven ability to prioritize.
• Works with a sense of urgency while engaging and listening to experts.
• Must be dependable and punctual.
• Fluent in English both written and spoken.

Position Type

• On-Site

Travel

• None