Visual Inspection & Drug Product Process Development Engineer – Sterile Injectables (JP15969)
About The Position
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.
Requirements
- Experience with Visual Inspections
- Basic Lab Experience
- Biosafety Lab
- Aseptic Technique
- Works well in a team, is open to feedback, and is willing to learn new things.
- 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.
Nice To Haves
- 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
Responsibilities
- 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.
- 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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
