Job Title:  Engineer - (JP10385)
Location: Thousand Oaks, CA. 91320
Employment Type:  Contract
Business Unit: Process Engineering
Duration: 1+ years (with likely extensions)
Posting Date:  06/02/22
Notes:  Only qualified candidates, please.  Hybrid position.  Candidate will be required to be on site half the week and may work remotely 1-2 days a week. Must have biotech background/experience, plus must have purification experience.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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 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.  Under guidance of senior staff, the Engineer performs the following:

• Transfer 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

Basic Qualifications:
Master’s degree
OR
Bachelor’s degree
Associate’s degree and 7 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience

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 purification processes/ equipment; scale up factors from, chromatography, 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

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:

• Strong understanding of data analysis tools
• Knowledge of biologics purification processes/ equipment; scale up factors from, chromatography

• *1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
• *Manufacturing experience must be biotech experience

Day to Day Responsibilities:
Staff will perform tech transfer of early clinical candidate molecules. In addition staff will support all processes (clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate

Red Flags:

• Multiple short duration jobs on resume
• No purification experience - critical experience (Chromatography, purification, USTF)
• Manufacturing experience - must be biotech experience

Interview process:
Phone screening followed by in-person interview.


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.