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Visual Inspection & Drug Product Process Development Engineer – Sterile Injectables (JP15969)

  • Thousand Oaks, CA
  • Biotech/Pharmaceutical

Job Title:   Visual Inspection & Drug Product Process Development Engineer – Sterile Injectables (JP15969)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial DP - ATO Site PD
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 09/8/26
Pay Rate: $41 - $46/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Visual Inspection & Drug Product Process Development Engineer – Sterile Injectables (JP15969) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
We are seeking an Engineer to support visual inspection and drug product process development for sterile injectable products. This hands-on role will focus on visual inspection studies, defect-standard and panel development, laboratory experimentation, technical documentation, and automation-related engineering activities.  Activities include:
 
Develop and maintain visual inspection defect standards and qualification panels.
  • Design, execute, and document laboratory and drug product characterization studies.
  • Establish and maintain GMP procedures supporting visual inspection and laboratory operations.
  • Analyze experimental data and communicate results to cross-functional teams.
  • Author protocols, reports, technology-transfer documents, and other technical documentation.
  • Gather user requirements and support engineering assessments for automation system installations.
  • Perform field evaluations and provide recommendations for existing equipment and systems.
  • Support clinical and commercial process introductions, technology transfers, investigations, and process improvements.
  • Collaborate with Process Development, Manufacturing, Engineering, Automation, Quality, Regulatory, and other functions.


Why is the Position Open?
Supplement additional workload on team


Top Must Have Skills:
  • Experience with Visual Inspections
  • Basic Lab Experience
  • Biosafety Lab Aseptic Technique
  • 4.) Works well in a team, is open to feedback, and is willing to learn new things.


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’s degree; or
Bachelor’s degree and two years of engineering and/or operations experience; or
Associate’s degree and six years of engineering and/or operations experience; or
High school diploma or GED and eight years of engineering and/or operations experience.


Preferred Qualifications:
  • Three or more years of pharmaceutical or biotechnology industry experience
  • Experience with visual inspection processes
  • Experience creating defect standards or inspection panels
  • Experience with biosafety laboratory practices and aseptic technique
  • Experience with sterile injectable or aseptic fill/finish processes
  • Laboratory or pilot-plant experience with process equipment
  • Experience with automation, computer programming, computerized systems, or robotics
  • Familiarity with cGMP requirements, technical transfer, root-cause analysis, risk assessments, FMEA, and statistical analysis
  • Strong experimental design, data analysis, technical writing, and cross-functional communication skills

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


Interview process:
1st 30 minutes with team lead

2nd 30 minutes with team
 
 
Regards,
 
3KC Talent Acquisition Team