Job Title: Engineer (JP10385 Location: Thousand Oaks CA. 91320 Employment Type: Contract Business Unit: Process Engineering Duration: 1 years (with likely extensions) Posting Date: 06/02/22 Notes: Only qualified candidates please. 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 Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: 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. 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 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: Masters degree OR Bachelors degree 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
Why is the Position Open Supplement additional workload on team.
Top MustHave Skill Sets:
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
Day to Day 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
Interview process: Phone screening followed by inperson interview.
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