Engineer Biotech Process Engineering JP10544
Engineer Biotech Process Engineering JP10544
Posted on :
06-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
06-04-2025
Job Description
Job Title: Engineer Biotech Process Engineering(JP10544
Location: Thousand Oaks CA 91320 (Hybrid 23 days/week onsite)
Employment Type: Contract to Hire
Duration: 12 months with likely extensions or conversion to permanent
Job posting date: 7/12/2022
Note: Hybrid position. Candidate will be required to be on site half the week and may work remotely 12 days a week. Must have biotech background/experience plus must have purification experience.
3 Key Consulting is hiring an Engineerfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Summary:
DayToDay Responsibilities:
Staff will perform tech transfer of early clinical candidate molecules. In addition staff will support all processes (clinical and commercial) executed in the facility performing process monitoring and responding to issues as appropriate
Red Flags:
Phone screen followed by Webex interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at other positions on our websitewww.3keyconsulting. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.
Location: Thousand Oaks CA 91320 (Hybrid 23 days/week onsite)
Employment Type: Contract to Hire
Duration: 12 months with likely extensions or conversion to permanent
Job posting date: 7/12/2022
Note: Hybrid position. Candidate will be required to be on site half the week and may work remotely 12 days a week. Must have biotech background/experience plus must have purification experience.
3 Key Consulting is hiring an Engineerfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Summary:
- 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 purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using singleuse technology. Will partner with manufacturing quality analytical and bench scientists to support a highly dynamic manufacturing facility.
JOB RESPONSIBILITIES:
Under guidance of senior staff the Engineer performs the following: - Transfer purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
- Provide technical support for successful scaleup transfer of process technology and for clinical and/or commercial manufacturing operation.
- Offer process validation support for latestage 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: - Masters degree OR
- Bachelors degree OR
- Associates degree and 7 years of Engineering or Operations experience OR
- High school diploma / GED and 8 years of Engineering or Operations experience
PREFERRED QUALIFICATIONS: - Masters Degree in Chemical or Biochemical Engineering
- 1 years of Process Engineering experience preferably related to scaleup principles and commercial cGMP manufacturing facilities
- Background in biologics tech transfer into commercial facilities
- Purification process knowledge:
- Knowledge of purification processes/ equipment; scale up factors from chromatography UF/DF 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 multitask and work in teams
- Excellent written and verbal communication skills with technical writing and presentation experience
- Must have biotech background/experience plus must have purification experience.
- Strong understanding of data analysis tools.
- Knowledge of biologics purification processes/ equipment; scale up factors from chromatography
- 1 years of Process Engineering experience preferably related to scaleup principles and commercial cGMP manufacturing facilities
- Manufacturing experience must be biotech experience
DayToDay Responsibilities:
Staff will perform tech transfer of early clinical candidate molecules. In addition staff will support all processes (clinical and commercial) executed in the facility performing process monitoring and responding to issues as appropriate
Red Flags:
- Multiple short duration jobs on resume
- No purification experience critical experience (Chromatography purification USTF)
- Manufacturing experience must be biotech experience
Phone screen followed by Webex interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at other positions on our websitewww.3keyconsulting. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
Key Skills
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