Engineer, Drug Product Process Development & Technology Transfer - (JP15153)

3 Key Consulting
  • Thousand Oaks, California
  • $36–$41 Per Hour
  • Autofill and Review
30+ days ago

Job Description

Job Title:   Engineer, Drug Product Process Development & Technology Transfer - (JP15153)Location: Thousand Oaks, CA. 91320Employment Type: ContractBusiness Unit: Commercial Drug ProductDuration: 1+ year (with likely extensions and/or conversion to permanent)Posting Date: 03/23/26Pay Rate: $36 - $41/hour W2Notes: Only qualified candidates need apply.3 Key Consulting is hiring an Engineer, Drug Product Process Development & Technology Transfer for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:Bachelor's degree with at least 1 year of Industry Experience (not internship or similar).The ideal candidate for this role should have a bachelor’s degree in any scientific or engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. The candidate should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills.This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time.As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of client. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.Why is the Position Open?Supplement additional workload on teamTop Must Have Skills:- Knowledge of and hands-on experience with various drug product technologies- Excellent project management skills and ability to escalate relevant issues to project lead and line-management- Ability to work independently and as part of a team with internal and external partnersDay to Day Responsibilities:
  • Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
  • Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
  • Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
  • Support development and maintenance of technology transfer tools (clinical and commercial)
  • Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
  • Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
  • Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
  • Development of digital tools and models by leveraging data analytics and programming skills
  • Support at scale characterization and/or process validation runs as person in plant
Basic Qualifications: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 experiencePreferred Qualifications:
  • B.S. in scientific or engineering discipline with 1‒3 years’ experience or M.S. in scientific or engineering discipline with 0‒2 years’ experience
  • Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
  • Knowledge of and hands-on experience with various drug product technologies
  • Displayed critical thinking, problem solving and independent research skills
  • Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
  • Excellent project management skills and ability to escalate relevant issues to project lead and line-management
  • Strong cross functional team player with good communication skills (oral and written)
  • Ability to work independently and as part of a team with internal and external partners
  • Good computer and organizational skills with strong attention to detail
  • Self-motivated with a positive attitude
Red Flags:- Fresh out of college- Not being a team player- No industry experienceInterview process:- Hiring Manager- Panel Interview- 1:1 with DirectorWe 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.

Numbers & Facts

LocationThousand Oaks, California
Salary$36–$41 Per Hour

Skills

  • Analysis Skillsunmatched
  • Asepsisunmatched
  • Change Controlunmatched
  • Communication Skillsunmatched
  • Computer Programmingunmatched
  • Consultingunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Analysisunmatched
  • Data Modelingunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • Drug Developmentunmatched
  • Drug Manufacturingunmatched
  • Drug Productsunmatched
  • Experiment Designunmatched
  • High School Diplomaunmatched
  • Manufacturingunmatched
  • Manufacturing/Industrial Processesunmatched
  • Microsoft Excelunmatched
  • Microsoft Officeunmatched
  • Minitabunmatched
  • Multitaskingunmatched
  • Organizational Skillsunmatched
  • People Managementunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Procedure Developmentunmatched
  • Process Analysisunmatched
  • Process Developmentunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Project Developmentunmatched
  • Project/Program Managementunmatched
  • Protocol Analysisunmatched
  • Record Keepingunmatched
  • Research Skillsunmatched
  • Risk Analysisunmatched
  • SAPunmatched
  • Scientific Principlesunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Statisticsunmatched
  • Team Lead/Managerunmatched
  • Team Playerunmatched
  • Technical Analysisunmatched
  • Technical Drawingunmatched
  • Technical Recruitingunmatched
  • Technical Supportunmatched
  • Technical Writingunmatched
  • Time Managementunmatched
  • Writing Skillsunmatched

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