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

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