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Engineer, Drug Product Development, Process Design & Experimentation Hybrid (JP14756)
Engineer, Drug Product Development, Process Design & Experimentation Hybrid (JP14756)3 Key Consulting • Thousand Oaks, California, USA
Engineer, Drug Product Development, Process Design & Experimentation Hybrid (JP14756)

Engineer, Drug Product Development, Process Design & Experimentation Hybrid (JP14756)

3 Key Consulting • Thousand Oaks, California, USA
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Job Title : Engineer Drug Product Development Process Design & Experimentation - Hybrid (JP14756)

Location : Thousand Oaks CA. 91320

Employment Type : Contract

Business Unit : Commercial Drug Product

Duration : 1 year(s) (with likely extensions and / or conversion to permanent)

Posting Date : 11 / 18 / 25

Pay Rate : $36 - $41 / hour W2

Notes : Only qualified candidates need apply. Hybrid - 2-3 days onsite per week. Flexibility for more onsite requirements may be necessary.

3 Key Consulting is hiring an Engineer Drug Product Development Process Design & Experimentation - Hybrid for a consulting engagement with our direct client a leading global biopharmaceutical company.

Job Description :

This is a hybrid position. 2-3 days onsite per week. Must have flexibility for more onsite work if necessary.

Our ideal candidate will have a B.S. and 2YOE in Pharma with drug product experience

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.

Why is the Position Open

Supplement additional workload on team.

Top Must Have Skills :

  • Good documentation practices (GDP)
  • Experience with visual inspection
  • Technical writing skills

Day to Day Responsibilities :

  • Supports the establishment of robust tactical and strategic objectives related to visual inspection
  • Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels establishment of GMP procedures related to operations)
  • Implements and documents off-line and on-site drug product characterization studies
  • Author and / or own high-quality process technology transfer and other technical documents
  • Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change efficiency and strong relationships
  • 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
  • Design execute and document primary data packages related to drug product design and process development and communicate key findings in presentations
  • Support one or more clinical and commercial process introductions or process transfers into client manufacturing network
  • 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 :

  • 2 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
  • 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.
  • Strong knowledge of quality systems and drug product manufacturing
  • Experience in a matrix team environment and interacting with Analytical Sciences Process Development Project Management Manufacturing Regulatory Compliance and / or Quality
  • Capable of organizing and communicating complex technical concepts to enable business decisions
  • Red Flags :

    No prior Pharma or Biotech experience.

    Interview process :

  • 2 interviews (manager and team)
  • Video via Microsoft Teams
  • We invite qualified candidates to sendyour resume to . Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

    Regards

    3KC Talent Acquisition Team

    Key Skills

    Joomla,Banking,C,Market Research,Bpcs

    Experience : years

    Vacancy : 1

    Hourly Salary Salary : 36 - 41

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