Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200)
About The Position
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
Requirements
- Experience with Visual Inspections
- Defect Standard Creations
- Biosafety Lab Aseptic Technique
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Nice To Haves
- 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
- previous intern experience is a plus
- experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics
Responsibilities
- 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
- 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
Career Level
Mid Level
Number of Employees
1-10 employees
