Process Development Engineer, upstream biologics (JP14405)

Job Title: Process Development Engineer, upstream biologics (JP14405) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: PD B23 Mfg Spt Duration: 1+ years with likely extensions and/or conversion to permanent Posting Date: 08/28/2025 Pay Rate: $36 - $41/hour W2 Notes: HYBRID 3/4 days onsite, 1-2 remote (activities permitting) at Thousand Oaks, CA. Standard Business hours with some after-hours support (on call for manufacturing support potentially twice a month for 2-4 hours). 3 Key Consulting is hiring an Engineer for a consulting engagement with our client, a leading global biopharmaceutical company. Job Description: The ideal candidate will be a Process Development Engineer with a strong foundation in upstream biologics, including suspension cell culture, bioreactor operations, and monoclonal antibody production. They will join the Drug Substance Technology Engineering team, supporting development and manufacturing of therapeutic products from clinical to commercial stages, applying process engineering knowledge for technology transfer and manufacturing in an advanced suite utilizing single-use technology. Qualifications: Bachelor’s in Engineering, Biology, or related field with 2-5 years of relevant experience, or Master’s degree with new graduates considered. Proficiency in data analysis tools like JMP, excellent communication skills, and ability to collaborate across functions are essential. Candidates with remote-only work experience, limited upstream experience, or from non-scientific backgrounds should be avoided. Responsibilities: Transfer cell culture processes for drug substance manufacturing and perform process improvements from lab to manufacturing Support scale-up, process transfer, and manufacturing operations Assist in process validation for late-stage processes Monitor processes and troubleshoot issues Analyze data and perform statistical process analysis Support deviations, CAPAs, and change controls Identify operational excellence opportunities Collaborate with Manufacturing, Quality, and Regulatory teams Preferred Qualifications: Master’s in Chemical or Biochemical Engineering 1+ years in Process Engineering, especially related to scale-up and cGMP manufacturing Experience in biologics tech transfer and cell culture processes Strong troubleshooting, analysis, and protocol development skills Excellent communication, technical writing, and presentation skills Top Skills: At-scale biologics cell culture experience Data analysis skills (JMP preferred) Excellent presentation and troubleshooting skills Knowledge of GMP and regulatory interactions Day-to-Day Responsibilities: Support upstream processes, perform process monitoring, and assist with tech transfer of clinical candidates. Qualifications: Master’s degree or Bachelor’s with 2 years of experience; Associate’s degree with 7 years of experience. Red Flags: Remote-only work, short-term job history, lack of upstream experience, non-scientific background, poor presentation skills. Interview Process: Video panel interview with team (1:4/6). Available to interview upon candidate identification. Application: Send resume to View email address on click.appcast.io . Visit our website for other opportunities: . Feel free to share this opportunity. #J-18808-Ljbffr 3key Consulting, Inc.