Sterile Technician

SUMMARY

The candidate will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the Sterile Production Technician will work hands on, under ISO7 and ISO5 area, with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set up, weighing of materials, manufacturing of batches, sterilization of product, submitting samples, performing filling operations under ISO5 environment.

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 Good Manufacturing Practices (GXP) guidelines.
• Gowning/Aseptic Technique Experience
• 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; weighing and measuring ingredients and adding to mixing equipment.
• Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
• Responsible to review all documentation including Batch records and Logbooks in “Real Time and Right First Time” and demonstrate error free documentations. Immediately reports any error or deviations noticed to management.
• Obtaining equipment and raw material for manufacturing and compounding.
• Follows all steps outlined in batch records.
• Ability to perform a batch record review in real time.
• Operation of Autoclave.
• Perform in-process filling checks and verification.
• Obtain Filling accessories.

QUALIFICATIONS

• High School diploma with 3 years -Pharma/Biotech Manufacturing Support and 1 year- within Clean Room environments and some technical certification is desired in related field.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure.
• Must possess technical knowledge to operate and troubleshoot all operating equipment with minimal help.
• Environmental Monitoring, Water, and product sampling.
• Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Ability to Accept & apply Lessons Learned as needed. Works with a sense of urgency, while engaging and listening to experts.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Strong organizational skills with the proven ability to prioritize.
• Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
• Ability to handle sensitive information with a high degree of confidentiality.