Process Development Engineer

Job Details:

Job Title: "Engineer"

Duration: 12 Months Contract

Location: Thousand Oaks, CA

Pay Rate: $35 to $40/hr on W2 (without benefits)

Must have skills:

• Specifically looking for upstream experience.
• Strong communication - must be comfortable speaking to a group of 20 manufacturing associates in presentation (data reviews/etc.)
• GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Job Summary:

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

Responsibilities:

• Transfer cell culture and/or purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
• Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
• Offer process validation support for late stage commercial processes
• Provide routine process monitoring and troubleshooting
• Execute data trending and statistical process analysis
• Support technical direction for process related deviations, CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

Skills:

• Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment
• 1 years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
• Background in biologics tech transfer into commercial facilities
• Cell culture and/or Purification process knowledge:
• Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
• Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
• Strong capability of analysis, troubleshooting and problem solving
• Ability to develop and follow detailed protocols
• Excellent written and verbal communication skills with technical writing and presentation experience

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, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Email ID: Shalini@UStechsolutionsinc.com

Internal ID: 25-35284