Aseptic Manufacturing Technician 1st or 3rd shift

Job Description

Job Overview:

The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing. The Manufacturing Technician will be responsible for cleaning and sanitization, preparation and / or filling of a range of pharmaceutical products for clinical and commercial use.

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

Sanitization

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

Preparation

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

Fill

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).