Engineer

Company: Aditi Consulting
Location: Newbury Park
Posted on: April 4, 2025

Job Description:

Payrate: $ 35.00 - $ 37.00/hr.

Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.

Summary:
The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

JOB RESPONSIBILITIES:Transfer cell culture and/or purification drug substance processes 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


PREFERRED QUALIFICATIONS:Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment
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 and/or Purification process knowledge:Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, process deviations, raw materials to 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 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


Top 3 Must Have Skill Sets:Specifically looking for upstream experience
Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)


Day to Day Responsibilities:Transfer upstream (cell culture & harvest) drug substance processes and facilitates 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 operations
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 collaborate with other functions such as Manufacturing, Quality, Engineering and Regulatory


Pay Transparency:
The typical base pay for this role across the U.S. is: $ 35.00 - $ 37.00 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology including calls from an AI Voice Recruiter.

#AditiConsulting

Keywords: Aditi Consulting, Los Angeles , Engineer, Engineering , Newbury Park, California