Engineer

Onsite

Top 3 Must Have Skill Sets:
1) Experience with Visual Inspections
2) Defect Standard Creations
3) Biosafety Lab Aseptic Technique

Job Details:

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.

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.

Additional Job Description:
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 Client manufacturing network

Preferred Qualifications
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

Basic Qualifications
Master's degree
Bachelor's degree and 2 years of engineering and/or operations experience
Associate's degree and 4 years of engineering and/or operations experience
High school diploma / GED and 6 years of engineering and/or operations experience