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Location:
Philadelphia, Pennsylvania, United States
Job reference: R-046907
Posted date: Mar. 14, 2019
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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 or Manufacturing Technician IV 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. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The candidate will be hired at either a Manufacturing Technician III or Manufacturing Technician IV based on their qualifications.
This job requires people to be available to work shifts: 2nd shift is 2:30 pm to 10:30 pm Shift Diff 10%; 3rd shift 10:30 pm to 6:30 am Shift Diff 15%.

The Manufacturing TechnicianIII / Manufacturing Technician IV perform 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. Training will be provided.

The Manufacturing Technician III and Manufacturing Technician IV are responsible for but not limited to the following:

  • All aspects in the aseptic manufacturing of product to ensure product quality and patient safety.
  • All manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.
  • Operate basic equipment (i.e. scale and/or balance, autoclave, pH meter, environmental monitoring equipment) as delineated in standard operating procedures.
  • 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.
  • Carry out assignments in a timely, diligent and safe manner to comply with Regulatory agencies both domestic and international (i.e. CFR, EMEA).
  • Accurately complete documentation to comply with FDA and GCP/GLP/GMP regulations.
  • 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.
  • Successfully complete aseptic operator training and qualification in support of production.  This includes aseptic gowning qualification.
  • Environmental monitoring of the manufacturing facility, sample/test clean utilities and aseptic handling/collection of critical utilities (i.e. water for injection).
  • Calibration, controls, and checks of all equipment in support of production and sample handling.
  • 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.
  • Work in a fast-paced environment as part of a team
  • Be flexible to work various manufacturing shift(s).
  • Effectively communicate both oral and written and utilize good listening skills.
  • Work with computers (navigating systems, recording information, using to find information to perform the job).

Qualifications for Maintenance Technician III

Education:

  • High school diploma or general education degree (GED) or Biologic Technician Certification or Associate Science Degree. 
  • Bachelor’s degree is a strong plus.
  • Certifications and licenses that are relevant are acceptable.

Required:

  • Minimum of three (3) 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 packaging experience is acceptable.
  • Proficient in the use of LMS and EDMS.
  • Demonstrated proficiency to initiate, investigate and close deviations and CAPAs in Trackwise.
  • Ability to work shifts: 2nd shift is 2:30 pm to 10:30 pm Shift Diff 10%; 3rd shift 10:30 pm to 6:30 am Shift Diff 15%.

Preferred:

  • Pharmaceutical experience is preferred.

Qualifications for Manufacturing Technician IV

Education:

  • High school diploma or general education degree (GED) or Biologic Technician Certification or Associate Science Degree. 
  • Bachelor’s degree is a strong plus.
  • Certifications and licenses that are relevant are acceptable

Required:

  • Minimum of six (6) years' related experience or training with no college degree or a minimum of four (4) years’ related experience or training with College degree.
  • 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 packaging experience is acceptable.
  • Proficient in the use of LMS and EDMS.
  • Demonstrated proficiency to initiate, investigate and close deviations and CAPAs in Trackwise.
  • Ability to work shifts: 2nd shift is 2:30 pm to 10:30 pm Shift Diff 10%; 3rd shift 10:30 pm to 6:30 am Shift Diff 15%.

Preferred:

  • Pharmaceutical experience is preferred.

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 / IV - Philadelphia, PA - Global Operations
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