2nd Shift Aseptic Manufacturing Technician - Hunt Valley, United States - Pharmaceutics International Inc

Pharmaceutics International Inc
Pharmaceutics International Inc
Verified Company
Hunt Valley, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

2nd Shift Manufacturing Technician (Aseptic, Fill Finish)
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Are you a Fill Finish Manufacturing Technician with experience in an Aseptic environment?
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Are you looking for an opportunity to work 2nd shift (3:00-11:30 PM) + 10% shift differential
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Would you like to join a company where you can take your career to the next level?
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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 realtime 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 onsite 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 noninherent 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
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