Aseptic Manufacturing Technician

Job Overview:

Responsibilities:

• Complete and maintain aseptic qualification training.
• Attain and maintain gowning qualification per appropriate SOPs.
• Follow SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail.
• Prepare and maintain accurate documentation following cGMP and GDP principles.
• Ensure documentations are completed in real-time in accordance to CGMP and GDP principles.
• Adhere to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions.
• Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.
• Work collaboratively with internal teams to meet site goals and objectives as part of a team.
• Initiate and foster a spirit of cooperation within and between departments.
• Review documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA).
• Maintain all personal cGMP related training in a current state.
• Achieve and maintain cleaning and sanitization of cleanroom training.  
• Participate in Aseptic media qualification per the appropriate qualification protocol.
• Support manufacturing in the investigation of deviations and performs required risk assessments.
• Participate in personnel monitoring as required.
• Work closely with Operational Excellence to identify and implement process improvements

• Complete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms.
• Accurately prepare, label, and use cleaning materials and solutions.
• Accurately sort and dispose of pharmaceutical waste materials.
• Perform additional equipment setup or preparation activities in support of production as assigned.
• Maintain all sanitation related equipment. 
• Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
• Achieve and maintain respirator and PAPR training as required

• Prep batch specific materials (staging) inside and outside of the cleanroom.
• Retrieve, prepare, stage, and deliver materials and supplies to production, packaging & inspection (finishing), and distribution center.
• Provide input and support to ensure availability of raw materials.
• Put items into stock (physical), perform cycle counts, support physical inventory counts at required frequency as needed.
• May transport recycling and packaging waste to final on-site disposal location.
• Wash, wrap and label reusable parts.
• Prepare reusable parts, load, and run autoclave in accordance with appropriate SOPs and protocols.
• Interact with HDMI interface including, vial rinser, autoclave depyrogenation tunnel and ovens.
• Perform assembly of and filter tubing assemblies per appropriate SOPs.
• Perform pre- and post-filter integrity testing as required.
• Transport materials, components, and equipment from the prep room to the designated material transfer room

• Set up and breakdown the filling equipment per appropriate SOPs.
• Transport equipment and components as needed. 
• Interact with filling machines at the validated speeds and volumes.
• Perform volume checks.
• Perform and document inherent and non-inherent interventions. 
• Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment.
• Work with R&D and tech transfer team for successful transfer of Programs into the GMP area
• Perform all aseptic connections, respecting first air.
• Perform pre- and post-filter integrity testing as required.
• Aseptically sterile filter products into appropriate vessels.
• Attain and maintain ability to perform environmental tasks as required.

• Perform other duties, as assigned.

Qualifications: 

• High school diploma, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• A minimum of 1 year of experience in a related field, preferred.
• Demonstrate basic math skills.
• Demonstrate an understanding of Aseptic filling and general production.
• Demonstrate knowledge of product lifecycle knowledge and risks.
• Demonstrate the ability to obtain the appropriate knowledge from resources on Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate the ability to acquire the appropriate knowledge from resources on electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate the ability to acquire the appropriate knowledge from resources on current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Able to obtain a good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). 27 To 36 (USD) Hourly