CSV Compliance Lead - Validation & SDLC Expert

Katalyst-Healthcares-; Rahway (NJ); On-site; USD 130,000 - 150,000; Full time

Job summary

Katalyst-Healthcares- seeks a CSV Engineer to lead Computer System Validation compliance for capital and strategic projects in a regulated pharmaceutical environment.

This role serves as the technical compliance authority for project teams, providing guidance on SDLC, CSA, qualification, and validation approaches, and authoring, reviewing, and approving validation lifecycle deliverables in line with applicable SOPs and regulatory requirements.

Qualifications

• 7+ years in CSV/CSA and automation compliance in regulated pharma/biotech environments.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11.
• Experience supporting capital projects and GMP computerized systems.

Responsibilities

• Lead CSV compliance activities for capital and strategic projects across sites.
• Author, review, and approve validation lifecycle deliverables (QAPs, risk assessments, requirements, test docs, reports).
• Provide guidance on SDLC, CSA, qualification, and validation approaches.
• Approve SDLC documents as the technical unit and support validation activities.
• Participate in project meetings, governance, and CSV compliance reviews.
• Assist with change controls, deviations, and CSV risk assessments.
• Maintain project CSV compliance trackers, metrics, and reporting.
• Communicate risks to the Global CSV Compliance Lead to minimize delays.

Education

Bachelor's degree in Engineering, Science, Computer Systems, or related

Job description

Katalyst-Healthcares- seeks a CSV Engineer to lead Computer System Validation compliance for capital and strategic projects in a regulated pharmaceutical environment.

This role serves as the technical compliance authority for project teams, providing guidance on SDLC, CSA, qualification, and validation approaches, and authoring, reviewing, and approving validation lifecycle deliverables in line with applicable SOPs and regulatory requirements.