10-15 years of experience in computer system validation (CSV) within pharmaceutical manufacturing.
Strong understanding of operational technology concepts and automation solutions, including PLC and SCADA systems.
Experience with AVEVA System Platform and AVEVA PI Historian integrations.
Hands-on background in testing field I/O, instrumentation, and control systems.
Familiarity with regulatory compliance in sterile manufacturing and CSV documentation processes.
Responsibilities
Support the validation of computer systems for a new sterile drug manufacturing facility.
Lead the development and execution of CSV documents according to company policies.
Collaborate with a team of automation engineers on system design and implementation.
Resolve technical protocol deviations within the R&D project team.
Transition to on-site work, ensuring project delivery aligns with critical deadlines.
Benefits
Hybrid work structure starting in 2026, transitioning to more on-site work in 2027.
Opportunity to work on high-impact projects during facility expansion.
Collaboration with a skilled team in a state-of-the-art facility.
Access to training and development resources.
Flexible work arrangements to accommodate project schedules.
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.
