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Engineer
Posted: 08/28/2025
Job Number: 41182
Job Description
Engineer
Top 3 Must Have Skill Sets:
- Must have at-scale biologics cell culture experience (manufacturing experience, engineering/equipment experience)
- Strong understanding of data analysis tools (JMP preferred)
- Excellent communication and troubleshooting (Must be comfortable presenting data & technical information to a group of 20+ people. Presenting at min once per month to quarter)
- 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. GMP experience is a huge plus - someone who has dealt with regulatory inspectors/auditors (FDA, other regulatory agencies from other countries)
Red Flags:
- Remote work only.
- Multiple short-term work experiences
- Lack of upstream cell culture/harvest experience
- Purification experience only
- Non scientific/engineering background/degree
- Not sociable
- Not good with presenting technical data
Summary:
The ideal candidate will be a Process Development Engineer with a strong foundation in upstream biologics, including suspension cell culture, bioreactor operations, and monoclonal antibody production. The engineer will join the Drug Substance Technology Engineering team, supporting the development and manufacturing of human therapeutic products from clinical stages through commercial production. They will apply process engineering knowledge to support technology transfer and manufacturing in an advanced suite utilizing single-use technology. The ideal candidate will hold a 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. They should be proficient in data and statistical analysis tools such as JMP, possess excellent communication skills, and thrive in cross-functional collaboration. Comfort working in a regulated, fast-paced environment and presenting technical data to diverse teams is essential. Candidates who are remote only, lack upstream experience, have excessive short-term job history, or come from non-scientific or non-engineering backgrounds should be avoided.
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
Basic Qualifications:
- Master’s degree
OR
- Bachelor’s degree and 2 years of Engineering or Operation experience
- Associate’s degree and 7 years of Engineering or Operations experience
OR
- High school diploma / GED and 8 years of Engineering or Operations experience
Preferred Qualifications:
- 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
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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.
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