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