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Fill Finish Aseptic Manufacturing Technician

2 months ago

Hunt Valley, United States Normann Staffing Services Full time

Apply today for a full time, direct hire opportunity with a large pharmaceutical client of ours in the Hunt Valley, MD area


Shifts: 1st shift: Mon-Fri 7 AM- 4 PM

2nd shift: Mon-Fri 3 PM- 12 AM + 10% shift differential

3rd shift: Sun-Thurs 11pm-8am + 15% shift differential


Salary: $27-$37/hour depending on experience


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 the filtration and filling of a range of pharmaceutical products for clinical and commercial use.


Responsibilities:

  • Complete and maintain aseptic qualification training.
  • Obtain basic understanding of a task, unit operation and/or document (forms and/or SOPs) while aiding with oversight from Manufacturing Technician III and above.
  • 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.
  • 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.
  • Perform other duties as assigned.


Qualifications:

  • High school diploma or equivalent with 1-3 years’ experience, Bachelor’s degree with a minimum of 1 year of experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
  • Prior experience in related field, preferred.
  • cGMP manufacturing knowledge, preferred.
  • Aseptic filling and general production knowledge, preferred.
  • Demonstrate basic math skills.
  • Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
  • Must be able to comprehend and follow all applicable SOPs.
  • Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
  • 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 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).