Career Category

Job Description

This position is for C-shift (Night rotation).

Under general supervision, employee will perform operations in the Purification area per Standard Operating Procedures. Employee will perform and monitor critical processes (Chromatography, UF/DF, LFH Operations, WIP Lab, SIP and CIP), execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee may perform basic troubleshooting and assist in the review of documentation for assigned functions including the initiation and ownership of NC/CAPA.  Additionally, the employee may identify, recommend, and implement improvements related to routine functions and participate on Cross-functional teams while representing the Purification Department.

Basic Qualifications

• Bachelor’s degree OR

• Associate’s degree & 4 years of directly related experience OR

• High school diploma / GED & 6 years of directly related  experience 

Preferred Qualifications:

- Knowledge of Purification operations

- Knowledge of WIP lab equipment and computers

- CFR and Regulatory knowledge

- Mechanical ability/expertise

- Basic statistical mathematical skills

- Ability to interpret and apply GMP knowledge

- Understanding of analytical methods for manufacturing area

- Ability to demonstrate technical writing capability (Trackwise experience)

- Ability to understand, apply and evaluate basic chemistry, biology and physical principles

- Basic troubleshooting skills

- Experience with Delta V, RDs, and the PI system