Likeremote

Subscribe to the latest remote jobs:

  • Likeremote jobs on https://LinkedIn.com/
  • Likeremote jobs on https://telegram.org/
  • Likeremote jobs on Reddit.com
KH

CSV Lead

Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Staff / Principal
4 months ago
  • PLC
  • SCADA
  • HMI
4 months ago
Auto apply with Likeremote
Not scoredNo CV on file. Upload one and this job gets a score out of 100.Upload CV
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

CSV Lead · Katalyst Healthcares & Life Sciences

Auto apply with Likeremote