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Process Development Engineer - Thousand Oaks, United States - ACL Digital
Description
Job Title:
Process Engineer
Location:
Thousand Oaks, CA
Duration:12 Months
Description:
ONSITE AT USTO
Currently seeing more documentation side and need to see hands on engineer experience with proper training/ background in technical side/ mathematics.
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 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 Amgen 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
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
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
Top 3 Must Have Skill Sets:
Looking for direct transferable experience in drug product manufacturing
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)
by Jobble
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