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
Travel