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:
Masters degree; or
Bachelors degree and two years of engineering and/or operations experience; or
Associates 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