Posted on: June 25, 2022
Title: Process Engineer
Location: Summit, NJ
Start date: ASAP
Responsibilities:The position will be responsible for the routine
MSAT support to our US CMO partners. This engineer will have
responsibilities like an internal MSAT organization for viral
vector manufacturing and fill/finish sites with the focus on
supplementing the technical capabilities of the CMO and driving
This person may be responsible for and support processes including
PPQ, commercial launch, and commercial manufacturing support.
The Process Engineer will support product lifecycle management,
including commercialization and evolution of cell therapy products
as well as day to day operations technical support at CMOs to
ensure reliable quality supply.
The role will be highly cross-functional and will interact with
other groups and in-country affiliates in establishing
manufacturing and technology capability, facility fit and design,
equipment selection, and facility start up work.
Provide remote technical troubleshooting support for manufacturing
activities at external manufacturing locations and when needed,
provide on-site technical process support of ongoing manufacturing
Create and revise technical documentation (e.g. changes controls,
SOPs, and batch records)
Perform deviation investigations and corrective and preventive
actions (CAPA) as a technical resource.
Author technically challenging deviations and drive them towards
Provide data collection, interpretation, and analysis on
manufacturing and manufacturing support processes. Determine areas
of opportunity, shifts and trends, and states of control
Collaborate with cross-functional teams, including the CMO joint
process team, Process Development, Manufacturing, Quality Assurance
and External Manufacturing.
Performing process fit-to-plant, equipment characterization and
scale-up, process Failure Modes and Effects Analysis (FMEA)-based
risk assessment, creation of Process Flow Diagrams and Bill of
Materials, review and approval of production Master Batch
Perform detailed review of Process Development processes and
generate technology transfer documents, including process
monitoring (manufacturing data analysis, summary, and presentation)
and authoring campaign summary reports.
Develop simulated process models to estimate throughput capacity,
resources and inventory levels.
Requirements:MSc or BSc in Biology, Chemical Engineering,
Biochemical Engineering or equivalent with 5+ years of relevant
experience in process development or commercial manufacturing.
Knowledge of CAR-T and/or lentiviral vector manufacturing a
OpEx and Lean Six Sigma project experience is strongly
Extensive experience in a regulated GMP manufacturing environment
(clinical and/or commercial)
Demonstrated ability to effectively work in cross functional teams,
meet deadlines, and prioritize multiple projects.
Experience in development and/or characterization of biologics
and/or cell therapy manufacturing processes.
Experience with cGMP, ICH guidelines, PPQ (process validation), and
working with a Quality organization.
Experience working in a self-driven, performance/results oriented,
fast paced matrix environment.
Experience or knowledge of creating computer-based process models
using process simulation software.
Experience or knowledge of statistical analysis using statistical
Able to creatively manage time and elevate relevant issues to
project lead and line management.
Strong scientific and technical writing.
Detail oriented with excellent verbal and written communication
Ability to travel domestically and internationally.
Keywords: Joule, New York , Process Engineer, Engineering , Summit, New York
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