Process Engineer/Visual Inspection

Job Title: Engineer/Visual Inspection

Location: Thousand Oaks CA/ONSITE

Duration: 12 Months

Description:

Top 3 Must Have Skill Sets:

1) Experience with Visual Inspections

2) Defect Standard Creations

3) Biosafety Lab Aseptic Technique

Skills: previous intern experience is a plus? experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.

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 Amgen 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