10-15 years of experience in Computer System Validation (CSV) processes
Strong technical knowledge of Automation solutions including monitoring and alarm management
Proficiency in AVEVA System Platform and Pi Historian
Hands-on experience with Allen Bradley and Siemens PLC systems
Experience in SCADA, HMI, and Client platforms with robust network infrastructure knowledge
Ability to work both independently and collaboratively within a team context
Familiarity with Robotic isolators and filling line control platforms.
Responsibilities
Lead and support the validation of computer systems for a new sterile drug product facility.
Develop and align CSV approaches with company policies, separate from existing commercial practices.
Guide the execution of validation documents throughout 2027 and into operations.
Handle communication and resolution of technical protocol deviations within the R&D team.
Provide flexibility in working hours to meet project delivery schedules as needed.
Assist in the transition phase of the facility to ensure seamless operations up to 2028.
Collaborate closely with Automation Engineers to optimize facility and equipment performance.
Benefits
Hybrid/flexible working structure transitioning to majority on-site presence in 2027.
Full Job Description
Responsibilities:
High Level Role 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.
Requirements:
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.
