Downstream/Purification Engineer

Job Title: Process Development Engineer

Location: Thousand Oaks CA

Duration: 12 Months

Description:

*Candidate will be required to be onsite 4-5 days a week and may work remotely 1-2 days a week.

*Candidate will be required to work Standard business hours with occasional after hour support

** Some after hours work may be required

Top 3 Must Have Skill Sets:

** 2 YOE post graduation required

At- scale biologics purification knowledge and experience

Strong understanding of data analysis tools

Excellent communication and troubleshooting

JOB RESPONSIBILITIES:

Under guidance of senior staff, the Engineer performs the following:

Transfer purfication drug substance processes and performs process improvements from the laboratory into the manufacturing facility

Provide technical support for successful scale-up, transfer of process technology, and for clinical and /or commercial manufacruring operation

Offer process validation support for late stage commercial processes

provide routine process monitoring and troubleshooting

Execute data trending and statistical process analysis

Support technical direction for process related deviations, CAPAs and change controls

Identify and support process related operational excellence opportunites

represent process devlopment and collaborates with other functions such as Manufacturing, Quality, and Regulatory

PREFERRED QUALIFICATIONS:

Master's Degree in Chemical or Biochemical Engineering

1+ Years of Process Engineering Experience preferably related to scale-up principles and commercial cGMP manufacturing facilities

Background in biologics tech transfer into commercial facilities

Purification process knowledge

Knowledge of purfication processes/equipment; scale up facors from chromtography, UF/DF, process deviations, raw materials to growth and quality attributes

Strong capability of analysis, troubleshooting and problem solving

Ability to develop and follow detailed protocols

Independently motivated with ability to multi-task and work in teams

Excellent written and verbal communication skills with technical writing and presentation experience

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience