Engineer, Process Development - Biopharma (JP12137)

Job Title: Engineer, Process Development – Biopharma (JP12137) Location: Thousand Oaks, CA. 91320 Business Unit: Commercial Drug Product Employment Type: Contract Duration: 1+ year(s) (with possible extensions) Rate : $38 - $42/hour W2 Posting Date: 01/08/2024 Notes: Hybrid: Working on site 25-50% of the time in Thousand Oaks, CA (some weeks you'll need to be there every day, some weeks not at all depending on contract need but MUST BE LOCAL) Highly prefer Master’s degree with experience or Bachelor's degree with at least 3 years of experience. 3 Key Consulting is recruiting a Process Engineer for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups. Specific responsibilities include but are not limited to: Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations Develop solutions to technical problems during process characterization and aseptic manufacturing . Support one or more clinical and commercial process introductions or process transfers into client’s manufacturing network Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships 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 experience Preferred Qualifications MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology 3+ years of experience within the pharmaceutical/biotechnology industry Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring Understanding of process related stresses that impact the quality and stability of biologics Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.) Familiarity with Design of Experiments (DOE) and Quality by Design (QbD) principles Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions Ability to learn and act on dynamic information at a rapid pace Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software. Laboratory or pilot plant experience with process equipment Top Must Have Skill Sets: Strong academic background or commercial GMP experience Ability to work in fast pace environment Lab or pilot plant experience Ideal candidate has solid manufacturing experience coming into the role (specifically being the "end user" in the manufacturing spectrum is great but not required) Day to Day Responsibilities: Support Process Development studies for multiple commercial programs with activities to tech transfer into new manufacturing suites or undergoing process improvement activities. Red Flags: This role will be a hybrid role. We can provide some flexibility for WFH, but working on-site as projects need is expected. Some weeks may be completely WFH, but some may require every day on-site work. Interview Process: Phone interviews is sufficient. We invite qualified candidates to sendyour resume to View email address on click.appcast.io . Ifyou 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 sharethis opportunity withanyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.