ACL Digital
Upsteram Process Development Engineer
ACL Digital, Thousand Oaks, California, United States, 91362
Overview
Job Title:
Process Engineer
Location:
Thousand Oaks, CA
Duration:
12 Months
HYBRID work arrangement: on-site 3-4 days per week, with 1-2 remote days (activities permitting).
Standard business hours with some after-hours support; on-call for manufacturing support potentially twice a month for 2-4 hours.
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 related scientific field with 2-5 years of relevant experience, or a master’s degree with new graduates considered. Proficiency in data and statistical analysis tools (e.g., JMP), excellent communication skills, and cross-functional collaboration are essential. Experience in a regulated, fast-paced environment and presenting technical data to diverse teams is required. Remote-only candidates, those lacking upstream experience, excessive short-term job history, or non-scientific backgrounds should be avoided.
Responsibilities
Transfer cell culture processes for drug substance manufacturing and perform 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory.
Basic Qualifications
Bachelor’s degree in Engineering or related field with 2 years of Engineering or Operations experience
Associate’s degree with 7 years of Engineering or Operations experience
High school diploma / GED with 8 years of Engineering or Operations experience
Preferred Qualifications
Master’s Degree in Chemical or Biochemical Engineering
1+ years of Process Engineering experience, preferably related to scale-up principles and CGMP manufacturing facilities
Background in biologics tech transfer into commercial facilities
Cell culture process knowledge: knowledge of cell culture processes/equipment; scale-up factors; mass transfer; metabolism; process deviations; raw materials; growth and quality attributes
Strong capability in 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
Key Skills
Scale-up biologics cell culture experience (manufacturing, engineering/equipment)
Strong data analysis skills (JMP preferred)
Excellent communication and troubleshooting; comfortable presenting data to groups (e.g., 20+ people; monthly to quarterly)
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Process Engineer
Location:
Thousand Oaks, CA
Duration:
12 Months
HYBRID work arrangement: on-site 3-4 days per week, with 1-2 remote days (activities permitting).
Standard business hours with some after-hours support; on-call for manufacturing support potentially twice a month for 2-4 hours.
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 related scientific field with 2-5 years of relevant experience, or a master’s degree with new graduates considered. Proficiency in data and statistical analysis tools (e.g., JMP), excellent communication skills, and cross-functional collaboration are essential. Experience in a regulated, fast-paced environment and presenting technical data to diverse teams is required. Remote-only candidates, those lacking upstream experience, excessive short-term job history, or non-scientific backgrounds should be avoided.
Responsibilities
Transfer cell culture processes for drug substance manufacturing and perform 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory.
Basic Qualifications
Bachelor’s degree in Engineering or related field with 2 years of Engineering or Operations experience
Associate’s degree with 7 years of Engineering or Operations experience
High school diploma / GED with 8 years of Engineering or Operations experience
Preferred Qualifications
Master’s Degree in Chemical or Biochemical Engineering
1+ years of Process Engineering experience, preferably related to scale-up principles and CGMP manufacturing facilities
Background in biologics tech transfer into commercial facilities
Cell culture process knowledge: knowledge of cell culture processes/equipment; scale-up factors; mass transfer; metabolism; process deviations; raw materials; growth and quality attributes
Strong capability in 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
Key Skills
Scale-up biologics cell culture experience (manufacturing, engineering/equipment)
Strong data analysis skills (JMP preferred)
Excellent communication and troubleshooting; comfortable presenting data to groups (e.g., 20+ people; monthly to quarterly)
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr