Manufacturing Technician II

Department Description

The Manufacturing Department performs small and large scale cell culture operations, equipment preparation, clean in place (CIP) and steam in place (SIP) of process equipment and the preparation/operation of filtration and chromatography systems.

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMPs.

• Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.

• Effectively demonstrates an understanding of GMPs and how they apply to specific responsibilities.

• Follows verbal and written procedures in operating production and equipment and performing processing steps; accurately completes appropriate production documentation.

• Maintains cleanliness and orderliness in the process area.

• Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSAT, Validation, etc.

• Utilizes manufacturing knowledge to improve process operations and affect positive change.

• Demonstrates ability to troubleshoot basic mechanical operations.

• Effectively utilizes Microsoft Office applications.

• Performs in-process analytical testing.

• Demonstrates general knowledge of automation systems

• Contributes to the continuous improvement of the manufacturing operation

• Demonstrates general knowledge and practice of aseptic techniques

Basic Qualifications

High School diploma/GED and cGxP manufacturing experience typically acquired with 1-3 years’ in this environment, or Bachelor’s degree with no prior cGxP experience

Preferred Qualifications

• Degree in Life Sciences

• Previous experience in a cGXP environment

• Previous experience with Cell Culture and/or Aseptic Technique

• Familiarity with Manufacturing Control Systems (i.e. Delta V)

Special Working Conditions

• Ability to lift up to 40 lbs.

• Ability to stand for 6+ hours in a production suite.

• Ability to gown and gain entry to manufacturing areas.

• Ability to work a twelve-hour rotating shift and every other weekend, including holidays as scheduled.