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Location:
Philadelphia, Pennsylvania, United States
Job reference: R-038221
Posted date: Oct. 28, 2018
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At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Manufacturing Technician III in Philadelphia, PA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.

We currently have Manufacturing Technician III positions available in our Red Lion Road, Philadelphia site. These roles requires availability to work shifts. 2nd shift is 2:30 pm - 10:30 pm (Shift Diff 10%) and 3rd shift 10:30 pm - 6:30 am (Shift Diff 15%.)

The Manufacturing Technician III performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products.  Operates general manufacturing equipment, such as autoclaves, and automated aseptic filling lines.  Handles raw materials and intermediate or finished products. Assists in all direct manufacturing support functions such as Thaw, Blend, Fill, Stage, Prep, Environmental Monitoring (EM) and equipment preparation.  Assists in indirect manufacturing support functions, such as cleaning and sanitization of the facility.  Performs standard operating procedures to meet current good manufacturing practices (GMP). Accurately completes required documentation to comply with Federal regulations and assists with batch-record close-out.  Maintains product related records as required.  Author/revise SOPs and Batch records as needed.

Primary Activities

  • Responsible for all aspects in the aseptic manufacturing of product to ensure product quality and patient safety.
  • Responsible for all manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.
  • Able to operate basic equipment (i.e. scale and/or balance, autoclave, pH meter, environmental monitoring equipment) as delineated in standard operating procedures.
  • Able to prepare and formulate specially cleaners and/or solutions, etc. needed for
  • cleaning and/or to be used in the manufacturing processes and/or support areas were specified by standard operating procedures.  Incumbent must be cleared to wear air filtering (face mask type) respirators and personal protective equipment.
  • Able to carry out assignments in a timely, diligent and safe manner to comply with Regulatory agencies both domestic and international (i.e. CFR, EMEA).
  • Able to accurately complete documentation to comply with FDA and GCP/GLP/GMP regulations.
  • Able to physically lift and carry up to 40 lbs., without assistance, on an occasional basis and capable of working in various environmental environments including but not limited to ultra-low temperature spaces utilizing proper protective equipment and/or clothing.
  • Must be able to successfully complete aseptic operator training and qualification in support of production.  This includes aseptic gowning qualification.
  • Will be responsible for environmental monitoring of the manufacturing facility,
  • sample/test clean utilities and aseptic handling/collection of critical utilities (i.e. water for injection).
  • Responsible for calibration, controls, and checks of all equipment in support of production and sample handling.
  • Must be able to work in a fast paced environment as part of a team.  And flexible to work various manufacturing shift(s).
  • Must be able to effectively communicate both oral and written and utilize good listening skills.
  • Able to work with computers (navigating systems, recording information, using to find information to perform the job).
  • Able to work with Microsoft programs (i.e. Excel, Word, PowerPoint, Access), Experience in electronic tools such as SAP, LIMs, LMS, Maximo, and Trackwise are useful but not required.

Qualifications:

Education:

  • High school diploma or general education degree (GED) or Biologic Technician Certification or Associate Science Degree. 
  • Bachelors degree is a strong plus.

Required:

  • Manufacturing Technician III requires 3-6 years of related experience or training.  
  • Previous aseptic processing experience required.
  • Clean room work experience, food, medical device and/or pharmaceutical manufacturing or aseptic processing and/or assembly experience, which may include environmental monitoring, pharmaceutical warehousing,
  • Pharmaceutical experience is preferred, but not required.  Training will be provided.

Preferred:

  • Proficient in the use of LMS and EDMS. 
  • Demonstrated proficiency to initiate, investigate and close deviations and CAPAs in Trackwise.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

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Manufacturing Technician III - Philadelphia, PA - Global Operations
MedImmune

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