Engineer, Biopharma Upstream Process/Equipment Support (JP13874)
$79,040–$87,360 year
On-siteThousand Oaks, California, United States
Thousand Oaks, California, United StatesOn-siteContract$79,040–$87,360 yearBachelors Degree
ContractBachelors Degree
Job Summary
Conduct cell culture and purification process engineering support for technology transfer and clinical/commercial drug substance manufacturing. Perform process improvements from the laboratory into the manufacturing facility, provide technical support for scale-up, and offer validation support for late-stage commercial processes. Execute data trending, statistical process analysis, and routine monitoring while troubleshooting deviations, CAPAs, and change controls. Ensure preventative maintenance on equipment, coordinate project work, and support continuous improvement initiatives. Partner with manufacturing, quality, analytical, and bench scientists to represent process development in a single-use technology environment. Work onsite 3-4 days per week in Thousand Oaks, CA, with remote options 1-2 days.
Required Qualifications
- biotech background/experience
- cell culture/purification experience
- bachelor's degree
- 2 years of industry experience
- recent master's graduate
- chemical engineering
- biochemical engineering
- biology
- hands-on experience with mammalian cell culture
- bioreactors
- upstream cell culture equipment
- analyzing manufacturing data
- presenting findings to cross-functional teams
- directors
- large groups of manufacturing staff (20+)
- Strong communication and presentation skills
- work onsite 3–4 days per week in Thousand Oaks
- Process Development Engineer
- Drug Substance Technology Engineering team
- Thousand Oaks facility
- human therapeutic products
- clinical development
- commercial production
- cell culture and/or purification process engineering knowledge
- technology transfer
- clinical/commercial drug substance manufacturing
- single-use technology
- manufacturing, quality, analytical, and bench scientists
- Transfer cell culture and/or purification drug substance processes
- perform process improvements from the laboratory into the manufacturing facility
- technical support for successful scale-up
- transfer of process technology
- clinical and/or commercial manufacturing operation
- process validation support for late-stage commercial processes
- routine process monitoring and troubleshooting
- data trending and statistical process analysis
- technical direction for process related deviations
- CAPAs and change controls
- process related operational excellence opportunities
- Manufacturing
- Quality
- Regulatory
- Bachelor degree Chemical or Biochemical Engineering
- 2 years of experience GMP Environment
- 1+ years of Process Engineering experience
- scale-up principles
- commercial cGMP manufacturing facilities
- Background in biologics tech transfer into commercial facilities
- Cell culture and/or Purification process knowledge
- purification processes/ equipment
- scale up factors from chromatography
- UF/DF
- process deviations
- raw materials
- growth and quality attributes
- cell culture processes/ equipment
- mass oxygen transfer capabilities
- impact of metabolism
- Strong capability of analysis
- troubleshooting and problem solving
- Ability to develop and follow detailed protocols
- Independently motivated
- multi-task and work in teams
- Excellent written and verbal communication skills
- technical writing
- presentation experience
- Specifically looking for upstream experience
- Strong communication
- comfortable speaking to a group of 20+ manufacturing associates
- presentation (data reviews/etc.)
- GMP experience
- GMP background
- someone who has dealt with FDA/ inspectors/ auditors
- Ensure preventative maintenance is performed on equipment
- Coordinate and organize project work
- Support continuous improvement projects
- Candidates not comfortable with onsite needs
Desired Qualifications
- familiarity with downstream/purification processes
- Bachelor degree Chemical or Biochemical Engineering
- 2 years of experience GMP Environment
- 1+ years of Process Engineering experience
- preferably related to scale-up principles
- 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
- 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
- growth and quality attributes
- Strong capability of analysis
- troubleshooting and problem solving
- Ability to develop and follow detailed protocols
- Independently motivated
- ability to multi-task and work in teams
- Excellent written and verbal communication skills
- technical writing and presentation experience
- GMP experience highly preferred
- GMP background
- someone who has dealt with FDA/ inspectors/ auditors
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