Downstream Process Development Engineer

Job SummaryJob Title: Downstream Process EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescriptionTop 3 Must Have Skill Sets:Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scaleExperience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activitiesExperience in working with design and optimization of pharmaceutical processing unit operations including harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules.Ideal Candidate: 3-5 YOE in the tech transfer space. Education background in Chemical Engineering, Bioengineering or Biotechnology. Worked in the commercial pharma space. 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes. Tech transfer documentation. Prefers candidates with both lab and manufacturing experience but would prefer manufacturing experience over lab.Responsibilities:Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.Perform assignments that have clear and specific objectives and require investigation of limited number of itiate and complete routine technical tasks associated with Technology Transfer.Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.Apply engineering principles and statistical analysis, including design of experiments, to address processing issues and evaluate opportunities for process improvements.Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system municate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.Support non-standard shift organization and extended hours, as per business needs.Qualifications (Basic and Preferred):Education background in Chemical Engineering, Bioengineering or Biotechnology2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scaleExperience working with a commercial manufacturer of biologics using single-use technologyBasic understanding of cGMP requirements; experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activitiesExperience in working with the design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration for various biological molecules. Experience working with data and digital tools preferred.Proficient in the analysis of data generated from an array of analytical techniquesRegulatory knowledge and interactions and project management skillsStrong oral and verbal communication and presentation skillsEducation: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 experienceSeniority and EmploymentSeniority level: Mid-Senior levelEmployment type: ContractJob function/Industries: Pharmaceutical Manufacturing and Biotechnology ResearchNote: The original content included multiple references to related roles and postings not directly relevant to this specific job description. This refinement removes those extraneous items while preserving core responsibilities and qualifications. #J-18808-Ljbffr

Created: 2025-10-08