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2nd Shift Aseptic Manufacturing Technician
4 months ago
**2nd Shift Manufacturing Technician (Aseptic, Fill Finish)**
- **Are you a Fill Finish Manufacturing Technician with experience in an Aseptic environment?**
- **Are you looking for an opportunity to work 2nd shift (3:00-11:30 PM) + 10% shift differential**
- **Would you like to join a company where you can take your career to the next level?**
- ** if so, this may be the perfect opportunity for you**
**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
- 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.
**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 o
