Manufacturing Technician

Job responsibilities:

• 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 work in a aseptic manufacturing environment complying with Regulatory agencies both domestic and international (i.e. CFR, EMEA). This includes provisions related to wearing jewelry (rings, necklaces, and watches), loose fitting items, make-up, and any similar items.
• 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.
• Special Skills/Abilities: Proficient in the use of LMS and EDMS. Demonstrated proficiency to initiate, investigate and close deviations and CAPAs in Trackwise
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

ESSENTIAL:

• High school diploma or general education degree (GED) or Biologic Technician Certification or Associate Science Degree
• 3-6 years of related experience or training.

DESIRABLE:

• Bachelors degree is a strong plus.
• Aseptic processing experience in the bio/pharmaceutical industry.
• 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.

Date Posted
05-Jan-2023

Closing Date
09-Mar-2023

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.