Process Development Engineer, upstream biologics (JP14405)
- Thousand Oaks, CA
- $36.00-41.00 per hour
- Contract
- Full-time
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: PD B23 Mfg Spt
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/28/2025
Pay Rate: $36 - $41/hour W2
Notes: HYBRID 3/4 days onsite, 1-2 remote (activities permitting) at Thousand Oaks, CA. Standard Business hours with some after-hours support (on call for manufacturing support potentially twice a month for 2-4 hours).3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:
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.JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer performs the following:
- 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 RegulatoryPREFERRED 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
- 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)
Staff will support all upstream processes (clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate. In addition, staff will perform and/or support tech transfer of early clinical candidate molecules.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 experienceRed 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 dataInterview process:
Video interview panel with team (1:4/6)
*Available to interview when the candidate is identified*We invite qualified candidates to send your resume to . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.