Drug Product Visual Inspection Process Development Engineer (Aseptic FillFinish) (JP15200)

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profile Job Location:

Thousand Oaks, CA - USA

profile Hourly Salary: $ 36 - 41
Posted on: 6 days ago
Vacancies: 1 Vacancy

Job Summary

Job Title: Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200)
Location:Thousand Oaks CA. 91320
Employment Type:Contract
Business Unit:Commercial Drug Product
Duration:1 year with likely extensions and/or conversion to permanent
Posting Date:04/3/2026
Pay Rate:$36 - $41/hour W2
Notes:Only qualified candidates need apply.

3 Key Consulting is hiring anEngineer Drug Product Process Development & Technology Transferfor a consulting engagement with our direct client a leading global biopharmaceutical company.


Top Must Have Skills:
1) Experience with Visual Inspections
2) Defect Standard Creations
3) Biosafety Lab Aseptic Technique



Job Description:
Position involves support of senior staff in the initiation design and delivery of projects particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.;

Skills: previous intern experience is a plus experience with automation is a plus as well as experience with computer programming systems and/or robotics.

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.



Key responsibilities include:
  • Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect standards and panels establishment of GMP procedures related to operations)
  • Supports the establishment of robust tactical and strategic objectives related to visual inspection
  • Implements and documents off-line and on-site drug product characterization studies
  • Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change efficiency and strong relationships
  • Support one or more clinical and commercial process introductions or process transfers into company manufacturing network

Preferred Qualifications
  • 3 years of experience within the pharmaceutical/biotechnology industry
  • Experience in development/characterization of drug product unit operations especially visual inspections
  • Understanding of process related stresses that impact the quality and stability of biologics
  • 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.)
  • Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
  • 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
Why is the Position Open
Supplement additional workload on team

Day to Day Responsibilities:
  • Supports ongoing hands-on lab-based development in visual inspection process development (i.e. development and maintenance of defect standards and 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.

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

Red Flags:
No Lab Experience
Not good with hands-on work.


Interview process:
2 Phone interviews.
1st 30 minutes with hiring manager
2nd 30 minutes with team

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

Required Experience:

IC

Job Title: Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200)Location:Thousand Oaks CA. 91320Employment Type:ContractBusiness Unit:Commercial Drug ProductDuration:1 year with likely extensions and/or conversion to permanentPosting Date:04/3/2026Pay Rate:$36...
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