Ability to work independently with minimal supervision
Strong communication and troubleshooting skills
Experience supporting large capital projects preferred
Responsibilities
Lead development and execution of CSV strategy and documentation
Support validation activities for computer systems associated with sterile drug product manufacturing
Develop and execute CSV lifecycle documents including protocols and reports
Collaborate with Automation Engineers and cross-functional project teams
Support investigation and resolution of technical protocol deviations
Participate in validation execution activities throughout the project lifecycle
Support testing activities related to field I/O, instrumentation, and control systems
Ensure compliance with cGMP and regulatory requirements
Benefits
Flexibility in work hours to accommodate project needs
Opportunity to work in a cutting-edge clinical manufacturing facility
Gaining experience in a dynamic project environment
Collaboration with a skilled team of Automation Engineers and other professionals
Involvement in the transition to a new facility planned for 2028
Full Job Description
Job Description:
We are seeking an experienced CSV Lead to support the validation of computer systems for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028.
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on leading and supporting the development of the CSV approach in alignment with company policies and independently from the existing commercial organization.
The consultant will lead the development and execution of CSV documentation and validation activities and is expected to support validation execution activities through 2027.
This position requires a highly experienced professional who can work independently in a fast-paced project environment and accommodate flexible work schedules as needed to support project delivery timelines.
Responsibilities:
Lead development and execution of CSV strategy and documentation.
Support validation activities for computer systems associated with sterile drug product manufacturing.
Develop and execute CSV lifecycle documents including protocols and reports.
Collaborate with Automation Engineers and cross-functional project teams.
Support investigation and resolution of technical protocol deviations.
Participate in validation execution activities throughout the project lifecycle.
Support testing activities related to field I/O, instrumentation, and control systems.
Ensure compliance with cGMP and regulatory requirements
Required Experience:
10-15 years of Computer System Validation (CSV) experience.
Strong pharmaceutical or biotech manufacturing experience.
