Job Title:Engineer Biopharma Upstream Process/Equipment Support (JP13874 Location:Thousand Oaks Ca 91320 Employment Type:Contract Pay Rate:$38.00 $42.00/hour W2 with benefits Business Unit:AMA Pilot Plant Duration:12 months with likely extensions and/or conversion to permanent Posting Date:03/28/25 Notes:Candidate will be required to be on site 34 days a week and may work remotely 12 days a week (activities permitting).
Must have biotech background/experience plus must have cell culture/purification experience.
3 Key Consulting is hiring! We are looking for an engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: The ideal candidate for the upstream engineer role is an earlycareer professional with a bachelors degree and 2 years of industry experience or a recent masters graduate preferably in chemical engineering biochemical engineering or biology. They must have handson experience with mammalian cell culture (not fermentation) bioreactors and upstream cell culture equipment along with a strong biotech industry background. The candidate should be comfortable analyzing manufacturing data and presenting findings to crossfunctional teams including directors and large groups of manufacturing staff 20. Strong communication and presentation skills are essential. While familiarity with downstream/purification processes is a plus it is not required. Candidates must be able to work onsite 34 days per week in Thousand Oaks. Red flags include a pure chemistry background without relevant lab experience and weak communication abilities.
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 singleuse 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 perform process improvements from the laboratory into the manufacturing facility
Provide technical support for successful scaleup transfer of process technology and for clinical and/or commercial manufacturing operation
Offer process validation support for latestage 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 scaleup 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 multitask and work in teams
Excellent written and verbal communication skills with technical writing and presentation experience
Top Must Have Skills:
Specifically looking for upstream experience
Strong communication must be comfortable speaking to a group of 20 manufacturing associates in presentation (data reviews/etc.
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)
Day to Day Responsibilities: Ensure preventative maintenance is performed on equipment Coordinate and organize project work Support continuous improvement projects
Red Flags:
Education purely in chemistry without relevant biology/engineering experience
Experience only in downstream/purification without upstream relevance
Lack of communication skills
Inability to summarize technical data
Candidates not comfortable with onsite needs
Pure chemistry background without relevant bio/eng lab experience Weak presentation abilities
Interview process: Phone screen followed by inperson or video panel interviews.
We invite qualified candidates to send your resume to If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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