Engineer

$35.00-$41.05 per hour

Thousand Oaks, CA Contract Duration:

12 months Contract Onsite

• 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 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
• Top 3

Must Have Skill Sets:

• + Experience with Visual Inspections + Defect Standard Creations + Biosafety Lab Aseptic Technique
• 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.

• About US Tech Solutions:

• _US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

To know more about US Tech Solutions, please visit_ _www.ustechsolutions.com_ _._ _"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"_