10-15 years of experience in automation and control systems within the pharmaceutical industry
Experience with key technologies like VEVA System Platform, Allen Bradley, and Siemens PLC
Proficient in SCADA, HMI, and network communications
Hands-on experience with testing field I/O, instrumentation, and control systems
Strong communication skills for collaboration and conflict resolution
Responsibilities
Support the validation of computer systems for a new sterile drug product manufacturing facility
Lead the development of the CSV approach aligned with company policies
Manage and execute CSV documentations through 2027
Resolve technical deviations within the R&D team
Collaborate with a team of Automation Engineers to ensure compliance
Benefits
Hybrid/flexible work structure available starting in 2026
Opportunity to work on high-impact projects in a newly constructed facility
Engagement in the full project lifecycle from development through execution
Collaborative team environment with seasoned professionals in automation.
Full Job Description
Roles & Responsibilities:
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
Experience:
lignment with existing Automation solutions: Particle and Equipment Monitoring, Alarm Management Systems
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
VEVA System Platform
llen Bradley and Siemens PLC
VEVA 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
