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Process Development Engineer

Thousand Oaks, CA 91320

Posted: 03/14/2024 Job Number: 38832

Job Description

Engineer

Top 3 Must Have Skill Sets:    
  • Purification experience, manufacturing experience, engineering experience
  • Experience with technical trouble shooting 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)
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 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:    
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
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

Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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