Engineer, Biopharma Upstream Process/Equipment Support (JP13874)

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 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. 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 early-career professional with a bachelor’s degree and 2 years of industry experience, or a recent master’s graduate, preferably in chemical engineering, biochemical engineering, or biology. They must have hands-on 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 cross-functional 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 3–4 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 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 perform 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 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 in-person or video panel interviews. We invite qualified candidates to send your resume to View email address on click.appcast.io. 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.