Crystal Equation
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Process Development Engineer
Top 3 Must Have Skill Sets:
Summary:
The ideal candidate for the upstream engineer role is an early-career professional with a bachelor’s degree and 2 years of industry experience, or a recent master’s graduate, preferably in chemical engineering, biochemical engineering, or biology. They must have hands-on experience with mammalian cell culture (not fermentation), bioreactors, and upstream cell culture equipment, along with a strong biotech industry background. The candidate should be comfortable analyzing manufacturing data and presenting findings to cross-functional teams, including directors and large groups of manufacturing staff (20+). Strong communication and presentation skills are essential. While familiarity with downstream/purification processes is a plus, it is not required. Candidates must be able to work onsite 3–4 days per week in Thousand Oaks. Red flags include a pure chemistry background without relevant lab experience and weak communication abilities.
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:
Preferred Qualifications:
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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. Â 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. Â We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
Process Development Engineer
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 03/31/2025
2025-03-31
2025-05-30
Job Number: 40471
Job Description
Process Development Engineer
Top 3 Must Have Skill Sets:
- 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)
- Education purely in chemistry without relevant biology/engineering experience
- Experience only in downstream/purification without upstream relevance
- Lack of communication skills
- inability to summarize technical data
- Candidates not comfortable with onsite needs
- Pure chemistry background without relevant bio/eng lab experience
- Weak presentation abilities
Summary:
The ideal candidate for the upstream engineer role is an early-career professional with a bachelor’s degree and 2 years of industry experience, or a recent master’s graduate, preferably in chemical engineering, biochemical engineering, or biology. They must have hands-on experience with mammalian cell culture (not fermentation), bioreactors, and upstream cell culture equipment, along with a strong biotech industry background. The candidate should be comfortable analyzing manufacturing data and presenting findings to cross-functional teams, including directors and large groups of manufacturing staff (20+). Strong communication and presentation skills are essential. While familiarity with downstream/purification processes is a plus, it is not required. Candidates must be able to work onsite 3–4 days per week in Thousand Oaks. Red flags include a pure chemistry background without relevant lab experience and weak communication abilities.
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
- Master degree
- Bachelor degree and 2 years of experience
- Associate degree and 6 years of experience
- High school diploma / GED and 8 years of experience
Preferred Qualifications:
- 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
- Independently motivated with ability to multi-task and work in teams
- Excellent written and verbal communication skills with technical writing and presentation experience
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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. Â 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. Â We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
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