Process Engineer

3 weeks ago

Thousand Oaks, United States ACL Digital Full time

Description:

HYBRID 3/4 days onsite, 1-2 remote. US Thousand Oaks USTO.

*Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).

**Must have biotech background/experience, plus must have cell culture/purification experience


Ideal Candidate: Exp. in a dynamic, fast based manufacturing environment adaptability, can jump around and pivot in their role with ease. sit in an open office and collaborate with team. Understand the language and compliance in a large scale manufacturing plant. Trouble shoot, problem solving and data analysis. Great communicator good technical witting and presentation exp. Min: Bachelor degree and 2 years of experience with antibodies or biologics.


Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.


The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.


JOB RESPONSIBILITIES:

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

- Transfer cell culture and/or purification 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 manufacturing 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 opportunities

- Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory


PREFERRED QUALIFICATIONS:

• Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment

• 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

• Cell culture and/or Purification process knowledge:

- Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, process deviations, raw materials to growth and quality attributes

- Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, 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


Top 3 Must Have Skill Sets:

Cell culture bioreactors - monitoring of at-scale bioreactor process/equipment. Or


Purification processes/ equipment; chromatography, UF/DF Ultra filtration and Dia filtration.


Experience working in a GMP plant and quality systems

Day to Day Responsibilities:

• Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation

• Provide routine process monitoring and troubleshooting

• Perform data trending and statistical process analysis

• Provide technical support for process related deviations (NCs), CAPAs and change controls

• Identify and support process related operational excellence opportunities

• Represent process development and interface with other functions such as Manufacturing, Quality, and Regulatory

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