10-15 years of Computer System Validation (CSV) experience.
Strong experience in pharmaceutical or biotech manufacturing.
Preferred experience with sterile manufacturing facilities.
Ability to work independently with minimal supervision.
Strong communication and troubleshooting skills.
Experience supporting large capital projects is preferred.
Responsibilities
Lead development and execution of CSV strategy and documentation.
Support validation activities for computer systems in sterile drug manufacturing.
Develop and execute CSV lifecycle documents including protocols and reports.
Collaborate with Automation Engineers and cross-functional teams.
Support investigation and resolution of technical protocol deviations.
Participate in validation execution activities throughout project lifecycle.
Support testing activities for field I/O, instrumentation, and control systems.
Ensure compliance with cGMP and regulatory requirements.
Benefits
Flexible work hours to accommodate project schedules.
Opportunity to work in a new Sterile Drug Product Clinical Manufacturing Facility.
Collaborative work environment with cross-functional project teams.
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.
