Computer System Validation Lead

Katalyst CRO; Lancaster (Lancaster County); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced automation validation professional to lead the CSV strategy for a new Sterile Drug Product Clinical Manufacturing facility in the US. The role will focus on developing and executing CSV documents, coordinating with the Automation team, and ensuring compliance with company policies while supporting the exit of the current facility.

With 10–15 years of hands-on experience and a strong ability to work independently, you will adapt to a hybrid/flexible work

Qualifications

• 10–15 years of hands-on automation/validation experience.
• Ability to work independently on complex validation projects.
• Strong communication to resolve technical deviations within R&D teams.

Responsibilities

• Lead and support development of CSV strategy for new sterile manufacturing facility.
• Develop and execute CSV documentation.
• Support validation execution through 2027 and adapt to project needs.

Skills

CSV validation leadership

Independent work

Technical communication

Tools

AVEVA System Platform

Allen-Bradley PLC

Siemens PLC

AVEVA Pi Historian

SCADA/HMI

Kneat

Job description

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.