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*Top 3 Must Have Skill Sets:   *

Purification experience, manufacturing experience, engineering experience

Experience with technical troubleshooting skills

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)

Description:

ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CA

STANDARD BUSINESS HOURS- SOME AFTER HOUR SUPPORT

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 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.

• onsite a minimum of 3 days a week

**Must have biotech background/experience, plus must have purification experience

*Basic Qualifications    *

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

*Day to Day Responsibilities:  *

Under guidance of senior staff, the Engineer performs the following:

• Transfer 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory

*Interview Process:      *

phone, asap

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 (http://www.ustechsolutionsinc.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.