CSV Lead, Sterile Drug Manufacturing Validation

Katalyst CRO

Philadelphia (Philadelphia County)

On-site

USD 150,000 - 210,000

Full time

8 days ago

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Katalyst CRO is seeking an experienced CSV Lead to validate computer systems for a new Sterile Drug Product Clinical Manufacturing Facility. You will report to the Automation Lead and collaborate with Automation Engineers to develop and execute CSV documentation and validation activities through 2027, ensuring cGMP compliance in a fast-paced project environment.

The role requires independent work, flexible hours, and strong cross-functional interactions with R&D and engineering teams to support

Qualifications

10-15 years CSV experience required.
Strong pharma/biotech manufacturing background.
Sterile manufacturing facility experience preferred.
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.