Computer System Validation Lead

Katalyst CRO; Lancaster (Lancaster County); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a candidate to support Validation of Computer systems for a Sterile Drug Product Clinical Manufacturing facility. The role is pivotal to the transition of the current facility by 2028 and will initially offer a hybrid work structure before requiring on-site presence from 2027.

Applicants should have substantial experience in validating systems and be capable of independent work, with a focus on developing CSV documents and resolving technical challenges within the R&D team.

Qualifications

• Experience in validation of computer systems for sterile Drug Product Clinical Manufacturing facilities.
• Ability to work independently with project timelines that may extend through 2027.

Responsibilities

• Lead and support the development of the CSV approach aligning with company policies.
• Report to the Automation Lead and collaborate with the existing Automation Engineers.
• Develop and execute CSV documents throughout the validation phases.

Skills

Validation of Computer Systems

Project Management

Communication Skills

Problem Solving

Tools

AVEVA System Platform

Allen Bradley and Siemens PLC

AVEVA Pi Historian

SCADA

HMI

Job description

Overview

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.

Responsibilities

• 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 be 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 through the year 2027.
• Project dynamics require ~10-15 years experience and the ability to work independently.
• Project dynamics could require flexible work as needed to accommodate project delivery schedule.
• Communication skills to resolve technical protocol deviations within the R&D project team.

Qualifications / Experience

• Experience in validation of computer systems for sterile Drug Product Clinical Manufacturing facilities.
• Ability to work independently with project timelines that may extend through 2027.

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.