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Title: Process Development Engineer
Location: Thousand Oaks, CA
Here they want person to be onsite 25% of the time in California
Experience in development/characterization and tech transfer of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters (3-5 years of experience)
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
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
Intellectt INC
