A Sterile Manufacturing Technician is responsible for the manufacturing of sterile liquids for commercial distribution and clinical trials. Personnel in this position will support the production operation by handling aseptic cleaning and specializing in more than one of the processing areas (cleaning, formulation, aseptic filling, equipment preparation, terminal sterilization, etc). This includes but is not limited to operating manufacturing processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position will employ above average mechanical aptitude and acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Personnel in this position will provide support in inspection and packaging areas as required.

• Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.
• Serves as setup mechanic for all area specific filling equipment.
• Has mastery of multiple aseptic processing concepts and steps including aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization
• Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection.
• Provides training to other operators.
• Follows written procedures.
• Clearly and accurately document activities in batch records and logbooks.
• Performs basic math calculations.
• Performs in-process weight checks and component counting.
• Submits in-process samples to responsible departments.
• Performs cleaning of rooms, tools and equipment.
• Performs specific visual inspections based on clearly outlined checks and specifications for the finished product.
• Responsible to ensure that the product meets specification
• Maintain Aseptic Gown Certification.
• Operate Autoclave to prepare/sterilize supplies as needed.
• Read, understand and review SOP’s and Protocols as required.

JOB RESPONSIBILITIES:

• Operate, maintain, assemble & disassemble, clean and set-up applicable production equipment.

• Execute batch records and production of material promptly and with the highest quality standards.

• Maintain documentation and functional work areas to CGMP standards.

• Capable of lifting and moving heavy equipment parts and containers.

Qualifications:

Training or Experience:

• Must possess mechanical aptitude.

• Must be familiar with computer applications.

• Must possess knowledge of the metric weight system.

• Must be able to adhere to outlined procedures and practices and follow specific instructions.

• Must possess strong math skills, documentation skills, and organization skills.

• Must be able to lift up to 40-50 lbs.

• Must possess good manual dexterity.

• Must possess basic knowledge of CGMP’s.

• Must be able to transcribe detailed data accurately according to CGMP and SOP standards.

• Must be able to work overtime with little or no notice. Must maintain good attendance.

• Responsible for maintaining the company’s high standards of quality, to meet the day-to-day scheduling needs and have the ability to accomplish the departmental goals

Consistently operates in an ethical and safe manner; compliant with procedures and policies; builds trust; tells the truth; initiates transparency into problems; communicates issues openly. Builds strong, diverse teams; attracts and retains good people; develops and makes people better; empowers others; flawless execution in order to support all the multiple technology transfer running parallel

Continue to drive production and think outside the box to maximize output and try to balance personal life with continue changes on daily tasks requirements.

Ownership of the process and the products being manufactured. Doing it correctly the first time with pride and quality. Focus on working with your team members on ways to succeed

Education:

High School Diploma/Associate Degree preferred

Experience:

2 – 4 Years experience in CGMP/Aseptic Operations Background