3 Key Consulting, Inc. · 5 months ago
Process Development Engineer, upstream biologics (JP14405)
Thousand Oaks, CA
Full-time
Hybrid
Entry, Mid Level
$36/hr - $41/hr
2+ years exp3 Key Consulting is hiring a Process Development Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves supporting the development and manufacturing of human therapeutic products, focusing on upstream biologics processes and technology transfer.
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Responsibilities
Transfer cell culture processes for drug substance manufacturing 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
Qualification
Required
Bachelor's degree in Engineering, Biology, or a related scientific field with 2 to 5 years of relevant experience, or a master's degree with new graduates considered
Proficient in data and statistical analysis tools such as JMP
Excellent communication skills
Thrive in cross-functional collaboration
Comfort working in a regulated, fast-paced environment
Presenting technical data to diverse teams
Preferred
Master's Degree in Chemical or Biochemical Engineering
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 process knowledge: 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
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
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