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Computer System Validation Lead

Karwell Technologies

Lancaster, PA

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JOB DETAILS
SKILLS
Allen-Bradley, Autoclave, Automation, Automation Engineering, Clinical Facilities, Communication Skills, Computer Systems, Control Systems, Corporate Policies, Drug Manufacturing, Drug Products, Field Trials, Human Machine Interface (HMI), Input/Output, Instrumentation, Network Administration/Management, Programmable Logic Controller (PLC), Project Schedule, Research & Development (R&D), Security Equipment, Supervisory Control and Data Acquisition (SCADA), System Validation
LOCATION
Lancaster, PA
POSTED
2 days ago
Job Description:
  • 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.

About the Company

K

Karwell Technologies

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