What are the responsibilities and job description for the CSV Lead position at Katalyst CRO?
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.
- 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
- 10-15 years of Computer System Validation (CSV) experience.
- Strong pharmaceutical or biotech manufacturing experience.
- Experience supporting sterile manufacturing facilities preferred.
- Ability to work independently with minimal supervision.
- Strong communication and troubleshooting skills.
- Experience supporting large capital projects preferred.
- AVEVA System Platform.
- Allen Bradley PLC.
- Siemens PLC.
- AVEVA PI Historian.
- Alarm Management Systems.
- Particle and Equipment Monitoring Systems.
- Understanding of Operational Technology (OT) concepts.
- Hands-on experience supporting testing of field I/O, instrumentation, and control systems.
- Experience with SCADA, HMI, and Client platforms.
- Experience with communications and network infrastructure.
- Experience supporting Robotic Isolator and Filling Line systems.
- Experience supporting Lyophilization processes.
- Experience with Formulation and Wash Isolators.
- Experience supporting Autoclave and Equipment Wash systems.
- Experience with Door Interlocking PLC systems.
- Kneat experience preferred.
- Project schedule may require flexible work hours.
- Candidate must be comfortable working in a dynamic project environment.
- Strong collaboration skills required within R&D and engineering project teams.