CSV Lead

Karwell Technologies · Lancaster, Pennsylvania, United States

Location
Lancaster, Pennsylvania
Job Type
Full-time
Posted
May 15, 2026

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 pro...

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