Manufacturing Technician

Job Description

1st, 2nd, and 3rd shifts available

Overview :

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.

Job Description

• Assists in all direct manufacturing support functions such as Thaw, Blend, Fill, Stage, Prep, Environmental and 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 and revisor of SOPs and Batch records as needed.
• 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.
• Operates basic equipment (i.e. scale and / or balance, autoclave, pH meter, environmental monitoring equipment) as delineated in standard operating procedures.
• Prepares and formulates 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.
• 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.

Skills and Experience

Essential

Desirable