Computer System Validation Lead

• 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.
• 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.

Technologies

• Alignment with existing Automation solutions: Particle and Equipment. Monitoring, Alarm Management Systems.
• 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.