CSV Lead
Listed on 2026-07-01
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Engineering
Systems Engineer
Job Title
Roles & Responsibilities:
Position is supporting Validation of Computer systems in support of a newly constructed Sterile Drug Product Clinical Manufacturing facility
Position will serve a key role in delivery to accommodate the exit of the existing Sterile Drug Product Clinical Manufacturing facility in 2028
The role will have hybrid/flexible work structure in 2026, transitioning to a majority of on-site presence beginning Jan-2027
The focus of the role will be to lead and support the development of the CSV approach, in alignment with company policies, and independent of the existing commercial organization
The role will report to the Automation Lead and part of a team that currently has three (3) Automation Engineers familiar with the design of the facility and equipment systems
The role will lead the development and execution of CSV documents
It is expected that the role will extend into the execution phase of validation thru the year 2027
Experience:
Alignment with existing Automation solutions:
Particle and Equipment Monitoring, Alarm Management Systems
Project dynamics require ~ 10-15 years experience and the ability to work independently
Project dynamics could require for flexible work as needed to accommodate project delivery schedule
Communication skills to resolve technical protocol deviations within the R&D project team
AVEVA System Platform
Allen Bradley and Siemens PLC
AVEVA Pi Historian
Understanding of Operational Technology concepts
Hands on experience in the support of testing of field I/O, instrumentation and control systems
Experience with SCADA, HMI and Client platforms, communications and network infrastructure
Independent control platforms to support Robotic isolator and filling line that will support multiple dose forms, with unique capability (Lyophilization)
Independent control platform to support Formulation and Wash Isolators
Independent control platforms to support Autoclave and Equipment Wash areas
PLC of Door Interlocking system
Kneat experience
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