Manufacturing Technician
AstraZeneca
Philadelphia, Pennsylvania
manufacturing
technician
manufacturing
aseptic
environmental monitoring
monitoring
operating
procedures
regulatory
cfr
items
training
qualification
March 2, 2023
AstraZeneca
Philadelphia, Pennsylvania
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.
- High school diploma or general education degree (GED) or Biologic Technician Certification or Associate Science Degree
- 1-3 years of related experience or training.
- 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.
Report this job