Aseptic Filling Operator - 2nd Shift

Siegfried•Irvine, CA

6d•Onsite

About The Position

The Aseptic Filling Operator position requires knowledge and ability to perform duties related to the manufacturing of drug products in a cleanroom environment, aseptic, device and assembled products utilizing reliable methods according to established procedures. Siegfried is a global network of 13 sites across three continents with a team of more than 3,800 highly skilled professionals. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof.

Requirements

Good oral and written communication skills
Good team and problem-solving skills
Initiative and manual dexterity
Ability to stand continuously for two or more hours while wearing proper gowning materials
Ability to work safely and use all material moving equipment in a safe manner
Basic math skills - there will be an assessment during the interview process
Ability to work overtime as necessary
High school graduate or equivalent
A minimum of 4+ years of industry experience
Pharmaceutical industry experience
Experience with cGMP and aseptic gowning for ISO 5/6

Responsibilities

Completes training modules regarding cleaning and sanitization methods for aseptic environments, this includes but is not limited to the use of germicidal/bactericidal/veridical/ agents, isopropyl alcohol, Sporklenz, Minnteck etc.
Completes training modules regarding gowning techniques for the entrance to and from ISO 5/6 designated areas.
Performs set up activities and operates aseptic filling machines.
Perform cleaning activities post fill.
Ability to assess the process performed, and if necessary, stop a line to insure a quality product.
Ensures good document practices in the recording, maintenance, reviewing and organizing of batch records, forms, documents and logbooks for responsible areas.
Assists other team members in manufacturing areas when needed.
Maintain good work place organization and housekeeping.
Responsible for adhering to applicable SOP, GMP and ISO rules and regulations related to the position.
More experienced Filling Operators will be responsible for training and instructing junior personnel to perform tasks following appropriate SOPs.