Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200)
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Overview
Career level
Senior-level
Remote
On-site
Compensation
$36-$41/hour
Job Description
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 - $41/hour W2Notes: Only qualified candidates need apply. 3 Key Consulting is hiring an Engineer, Drug Product Process Development & Technology Transfer for 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 TechniqueJob 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
- 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*
- 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.
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FAQs About Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200) Jobs at 3 Key Consulting
What is the work location for this position at 3 Key Consulting?
This job at 3 Key Consulting is located in Thousand Oaks, California, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at 3 Key Consulting?
Candidates can expect a pay range of $36–$41 per hour for this role.
What employment applies to this position at 3 Key Consulting?
The employer has not provided this information. This may be discussed during the hiring process.
What experience level is required for this role at 3 Key Consulting?
3 Key Consulting is looking for a candidate with "Senior-level" experience level.
What is the process to apply for this position at 3 Key Consulting?
You can apply for this role at 3 Key Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.