Lead CSV Engineer — Regulated Systems Validation

JobDiva, Inc.; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

JobDiva, Inc. in Cambridge, MA seeks an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computerized systems.

You will manage end-to-end CSV lifecycle, develop and review validation deliverables, and ensure systems meet regulatory requirements. The role requires 8–12+ years in CSV within pharma/biotech, strong knowledge of 21 CFR Part 11, Annex 11 and GAMP 5, and collaboration with IT, QA, and manufacturing.

Qualifications

• 8–12+ years of Computer System Validation experience in regulated environments.
• Strong understanding of GxP regulations and validation standards (21 CFR Part 11, Annex 11, GAMP 5).
• Experience validating enterprise systems such as LIMS, MES, ERP (SAP), QMS, DMS and related software.

Responsibilities

• Lead end-to-end CSV activities for GxP systems.
• Develop and review Validation Plans, Protocols, Risk Assessments and TRMs.
• Execute IQ, OQ, PQ activities and maintain lifecycle documentation.
• Coordinate with IT, QA, Engineering, Manufacturing and Business teams.
• Support internal and regulatory audits and inspections.
• Mentor junior CSV engineers and ensure SOP compliance.

Skills

CSV lifecycle management

Regulatory compliance

Risk assessments

Cross-functional collaboration

Mentoring

Education

Bachelor's or Master's degree in related field

Tools

LIMS

MES

ERP (SAP)

QMS

DMS

EBR

SCADA

PLC/HMI

Job description

JobDiva, Inc. in Cambridge, MA seeks an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computerized systems.

You will manage end-to-end CSV lifecycle, develop and review validation deliverables, and ensure systems meet regulatory requirements. The role requires 8–12+ years in CSV within pharma/biotech, strong knowledge of 21 CFR Part 11, Annex 11 and GAMP 5, and collaboration with IT, QA, and manufacturing.