10-15 years of experience in CSV or related fields
Proficient in automation solutions like AVEVA and Allen Bradley
Strong understanding of Operational Technology concepts
Hands-on experience with field I/O, instrumentation, and control systems
Experience with SCADA, HMI, and network infrastructure
Ability to work independently on complex projects
Exceptional communication skills for resolving technical issues
Responsibilities
Lead the development of the Computer System Validation (CSV) strategy
Support the execution of CSV documentation
Collaborate with the Automation Lead to align CSV approaches with company policies
Resolve technical protocol deviations within the R&D project team
Guide the transition to a new sterile drug product facility
Adapt work structure flexibly to meet project demands
Engage in validation execution extending to 2027
Benefits
Hybrid work structure starting in 2026
Opportunity to lead key validation projects
Collaboration in a skilled team of Automation Engineers
Impactful role in a state-of-the-art clinical manufacturing facility
Professional growth through challenging projects
Full 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.
