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Aseptic Manufacturing Technician

1 month ago

Union Valley, Texas, United States Active Staffing Services Full time
Job Summary

We are seeking a highly skilled Aseptic Manufacturing Technician to join our team at Active Staffing Services. As a key member of our manufacturing team, you will be responsible for supporting the overall GMP Fill Finish manufacturing processes, ensuring the quality and safety of our pharmaceutical products.

Key Responsibilities:

  • Support and demonstrate skill set to Manufacturing Technician I and Manufacturing Technician II.
  • 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.
  • 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.
  • Complete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed.
  • Attain and maintain ability to perform environmental tasks as required.
  • Additional duties, as assigned.

Requirements:

  • High school diploma or equivalent with at least 1-3 years of experience or Bachelor's degree with a minimum of 1 year of experience.
  • Mid level: 1-3 years of experience or Bachelors degree with a minimum of 1 year of experience.
  • Sr. Level 5 plus years of experience or a bachelors with a minimum of 3 years
  • Prior experience in related field, preferred.
  • Demonstrate the ability to work well in a cross-functional team environment.
  • Basic math skills
  • cGMP manufacturing knowledge, preferred.
  • Aseptic filling and general production knowledge, preferred.
  • Knowledge / Experience with electronic Quality Management Systems such as MasterControl
  • Must be able to comprehend and follow all applicable SOPs
  • Demonstrated ability to execute a task, unit operation and/or document (forms and/or SOPs) with little to no assistance.
  • Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products.
  • Demonstrate familiarity with Microsoft programs like Word, Excel, Teams and Outlook.
  • 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 managing priorities.
  • 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).
  • 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).